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    Im schönen Süddeutschland sucht unser Kunde, ein ‘Big Player’ in Sachen Medizinprodukten, mehrere Manager mit unterschiedlichen Stärken.

    Stellen in diesem Bereich ziehen sich von dem ‘üblichen’ RA Manager Skillset bis zum Fokus auf Europa bis zu Schwerpunkten in Hochrisikoklassen, Compliance, Submission und vielem mehr. Kandidaten aus allen Bereichen der Zulassung im Hinblick auf Medical Devices sind gerne gesehen.

    Überschneidende Aufgabengebiete sind (mit Ausnahmen):

    • Einhaltung und Identifizierung von Regularien in den verschiedenen Schwerpunkten
    • Technische Dokumentation
    • Dossierpflege
    • Korrespondenz mit den zuständigen Behörden
    • Vorbereitung und Unterstützung von Audits

    Je nach Stelle sollte Ihr Profil so aussehen (Abweichungen möglich):

    • Abgeschlossenes Studium im medizinischen/technischen/naturwissenschaftlichem Bereich oder eine vergleichbare Ausbildung
    • Mehrjährige Erfahrung im Bereich Medical Devices (Medizinprodukte)
    • Mehrjärige Erfahrung im Bereich Regulatory Affairs im Hinblick auf Medical Devices
    • Kenntnis von MDD / MDR, MDCG; (REACH & RoHS)
    • Starke Kommunikations- und Teamfähigkeit
    • Gute Kenntnisse in Deutsch und Englisch

    Erkennen Sie sich in der Beschreibung wieder?
    Wir freuen uns auf Ihre Bewerbung!

    Melden Sie sich gerne unter
    +49 69 50 955 654
    fritz.koester@skillsalliance.com

  • Quality

    Negotiable
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    Michael Parker at skills alliance is recruiting a Senior QC Operative. I am working with one of the largest privately owned import and distribution companies in the UK. They are based in the West Midlands, just outside of Birmingham. They are looking for a several new roles in QA working across both GMP, GDP & QC. Over the pandemic their ability to be nimble has meant they have actually grown and have made several hires in QA this year.

    Overall Objective:
    To be efficient in processing the work within the QC Department. Have a good knowledge of and always adhere to the company’s Standard Operating Procedures and comply with both Good Manufacturing Practice and Good Distribution Practice at all times. To comply with all company Health & Safety Policies, Procedures, Work Practices ensuring accuracy and quality and any other Health & Safety requirements at all times.
    __________________________________________________________________________________________
    Duties and Responsibilities:

    • Review and inspect incoming EU deliveries to verify the consignment has been received in an acceptable condition with no visible damages, indication of tampering, and that it is from an approved active supplier. The consignment was shipped securely under acceptable environmental conditions by an approved transport provider. Any products requiring special or secure storage requirements (temperature sensitive stock or controlled drugs) are processed in a timely manner and transferred to the appropriate location.
    • Record all relevant details of deliveries received on the company system.
    • Performing identity checks on raw product and reporting any discrepancies with the associated specification.
    • Ensuring all checks are recorded accurately during identification check.
    • Ensuring photographs of raw product are taken showing all faces (outer and inner) with batch number, expiry date and EU/ECMA visible and attached to batch documentation.
    • Ensuring all Italian sourced consignments undergo a Bollino authenticity check.
    • Ensuring all Greek sourced stock undergoes a Vignette authenticity check.
    • In process checks during production.
    • Performing a line clearance prior to and post QC final verification checks and completing the line clearance logbook accordingly.
    • Ensuring all relevant documentation is present with the working BPR and confirmed as complete.
    • Inspect materials or products being produced and recording outcomes in the relevant documentation.
    • Compering materials or products against a pre-defined standard specification.
    • Approving or rejecting components, packaging materials and finished products.
    • Ensure that if errors occurred, that they have been reported.
    • Check performs on the pre-printed packaging materials:
    • Removing and checking number of samples specified in the sampling plan for packaging material (number of samples is determined by QA personnel).
    • Escalating any quality defects to the QA who will assess the conformance or non-conformance of packaging material.
    • Performing identification check on the random sample that represents the batch; if any discrepancies related to the starting material or/and finished product found at this point, QC quarantines the whole unit.
    • Reviewing the batch records and ensuring all entries are inserted accurately.

    Support QC Manager:

    • Ensuring QC staff always comply with the applicable GMP requirements and associated processes and procedures.
    • Reporting any errors/non-compliances as quality incidents. Ensuring the details of any events or deviations raised are accurately recorded in the applicable controlled document (including the corresponding references).
    • Informing the operations manager of product related quality incidents as soon as possible.
    • Escalating any issues or concerns to The Quality Director, GMP QA Manager or RP.
    • Provide advice to staff regarding the quality standards.
    • Monitor operations to ensure compliance with quality standards.
    • Providing assistance to production staff where necessary regarding the quality standards.
    • Ensuring all retention samples are stored securely.
    • Ensuring all completed and signed batch records are stored securely.
    • Monitoring retention periods for batch documentation and retention samples.


    This is an urgent role so please get in touch as soon as possible if you are interested.

  • Quality

    Negotiable
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    Michael Parker at skills alliance is recruiting a QA Officer to specialise in GDP. I am working with one of the largest privately owned import and distribution companies in the UK. They are based in the West Midlands, just outside of Birmingham. They are looking for a several new roles in QA working across both GMP, GDP & QC. Over the pandemic their ability to be nimble has meant they have actually grown and have made several hires in QA this year.

    Overall Objective:
    Provision of QA support for the management and continual improvement of the company QMS, to ensure it meets the requirements of the company licences (including WDA(H)s and MIA), and the relevant parts of GDP and GMP at all times.
    Work effectively with other departments within the business as necessary, to ensure compliance with all relevant company and regulatory standards and maintain the safety, quality and efficacy of all products procured, handled, repackaged and supplied by the company.
    Support other members of the Quality department as necessary.


    Duties and Responsibilities:

    • Support maintenance and continual improvement of the company QMS by preparation, review, approval, training and implementation of SOPs and work instructions, as necessary.
    • Monitor changes in applicable GMP/GDP legislation and guidelines and support implementation of any necessary changes.
    • Identify compliance gaps and make recommendations for continuous improvement.
    • Manage own workload to ensure all tasks are completed within the timelines assigned to meet business needs and customer requirements.
    • Ensure the requirements of applicable product licences (e.g. PLPI, PLGB) are considered and adhered to as necessary.
    • Investigate and report quality incidents, utilising root cause analysis tools as necessary and applying an appropriate risk-based approach. Ensure all quality events and deviations are investigated to an appropriate level and are completed and reported in a timely manner.
    • Propose, implement, and monitor appropriate CAPA plans to address the root cause (or other causal/contributing factors) of non-conformances and ensure the effectiveness of all actions is monitored, as necessary.
    • Investigate and report complaints in a timely manner.
    • Prepare, co-ordinate and manage change controls.
    • Compile and review periodic product quality review reports.
    • Support product recalls where necessary.
    • Perform risk assessments.
    • Perform and report internal and external audits and housekeeping inspections, in accordance with the company audit schedules.
    • Support customer audits and regulatory inspections, as necessary.
    • Document control and archiving-adding new documents to Master Document List, ensure controlled documents are reviewed by periodic review date. Issuing controlled documents and reconcile superseded versions and archiving quality documents.
    • Review QMS documents (e.g. SOPs, work instructions, events, deviations, change controls etc.), ensuring all necessary requirements and standards are considered and approve as necessary.
    • Perform required checks to verify the authenticity of supplied products.
    • Prepare and deliver training, including preparation of training materials and competency assessments.
    • Perform and attend all necessary training and ensure a record of all training is maintained.
    • Perform qualification and/or quality audits and assessments to support approval of suppliers, customers, and service providers.
    • Monitor all suppliers, customers and service providers to ensure they are maintained in a qualified / approved status, taking into account any supply, service or other issues arising during routine use.
    • Generate and review Technical Agreements (TAs) with suppliers, customers and service providers.
    • Monitor the QMS and perform trend analysis. Propose and implement CAPA to address the outcomes from trend analysis as necessary, including potential process efficiency improvements.
    • Provide data, metrics and reports as necessary to monitor the suitability and effectiveness of the QMS. Attend and contribute to Quality Management Review (QMR) meetings. Generate minutes and actions of meetings when required.


    This is an urgent role so for full details please get in contact as soon as possible.


  • Quality

    negotionable
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    Michael Parker at Skills Alliance is currently recruiting several extremely exciting GCP auditor roles. My client are an exciting consultancy that have huge growth plans. The consultancy specialises in QA work solely across all areas of GxP.

    This role is to focus on their huge demand of GCP work their clients need, the clients range from small hyper growth Biotechs to large pharma.

    This is a great opportunity for someone with circa 5 years+ GCP auditing experience to broaden their experience and gain invaluable training and development. You will also get the opportunity to work with UK or global clients as well as get experience in other areas of GxP should you desire.

    The role will cover all areas of external auditing and be completely home based + travel. Below are some of the key responsibilities

    • Plan, conduct, report and follow up contracted audits within agreed budget and timelines
    • Conduct technical peer reviews and provide feedback on client deliverables
    • Assist with the preparation and facilitation of audits and regulatory inspections of clients, and work with responsible parties to prepare Corrective Action and Preventative Action (CAPA) plans as applicable
    • Provide strategic advice to clients on Quality Management System development and change
    • Provide a consultancy service for GCP and/or additional regulations
    • Develop and deliver training programs and/or materials
    • Manage the fulfillment of assigned contracted activities, identifying identify and escalate any potential out-of-scope activities
    • Keep relevant manager(s)/project manager, and the client where applicable, informed of the progress of all assigned contracted activities and any issues that may arise by providing regular updates and maintaining effective communication
    • Foster and maintain good, professional working relationships with clients and identify new business opportunities
    • Assist with the preparation of proposals and presentations to prospective clients

    Skills Required

    • Thorough knowledge of GCP and/or other applicable regulatory requirements
    • Excellent attention to detail, organisation, and prioritisation skills
    • Strong interpersonal skills, verbal and written skills, and the ability to communicate confidently at all levels
    • Self-motivation and ability to function independently and within a team
    • Ability to function calmly under pressure
    • Practical and enquiring approach to problem-solving
    • Dedication to quality and reliability in all aspects of work
    • Responsiveness to customer needs and focus on customer satisfaction

    This role is urgent so please get in touch as soon as possible if this is something you are interested in. Please note this role is only eligible for candidates based in the UK or eligible to work in the UK without sponsorship.

  • Quality

    €35000 - €45000 per annum, 38,5 Stunden, Flexible Arbeitszeiten, Job-Ticket, 13 Gehälter
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    Unser großer Big Pharma Kunde sucht für seinen neuen Standort in Hamburg eine*n Labortechniker*in in der Qualitätssicherung.

    Ihre Aufgaben:

    • Biochemischer und physikalischer Analytik von Rohstoffen, Hilfsstoffen und APIs im Zusammenhang der mRNA-Herstellung
    • Begleitung der Musterzüge von Rohmaterialien und weiteren chemischen Hilfsstoffen
    • Sicherstellung einer GMP-gerechten Dokumentation
    • Assistenz in der Methodenvalidierung durch Zusammenarbeit mit fachlichen Experten
    • Optimierung von Analysemethoden in Zusammenarbeit mit den Fachabteilungen
    • Handling von Rückstellmustern, Kontrolle von GMP Dokumentationen, Bearbeitung von OOX Untersuchungen und Abweichungen
    • Erstellung von Prüfmethoden, SOP’s und Bedienungsanleitungen


    Ihr Profil:

    • Abgeschlossene Berufsausbildung als Chemielaborant, CTA, Biologielaborant, BTA, PTA oder vergleichbar
    • Berufserfahrung im GMP-regulierten Umfeld sowie Kenntnisse und Erfahrungen in der (bio)chemischen Analytik von Arzneimitteln oder artverwandten Stoffen
    • Möglichst Kenntnisse und Erfahrungen in den analytischen Methoden der Photometrie, Kapillarelektrophorese (CE), Arzneibuch Methoden (Ph. Eur.)
    • Sehr gute Deutschkenntnisse in Wort und Schrift sowie möglichst Englischkenntnisse gut in Wort und Schrift

    Erkennen Sie sich wieder?
    Senden Sie gerne Ihre Bewerbung oder Ihre Rückfragen an:

    Fritz Köster
    fritz.koester@skillsalliance.com
    +49 69 955 654

  • Clinical Operations

    £60000 - £78000 per annum, excellent package
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    A rare opportunity to join a growing Gene Therapies focussed Biotech. This is a permanent Senior Clinical Study Manager role based in Central London.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They are expanding at present and will offer great long-term prospects. The company are looking for a very experienced Senior Clinical Study Manager or Senior Clinical Trial Manager, this would be working on complex and fast-paced studies from phase I-III. They require substantial clinical trial management experience, ideally experience in early phase, complex TAs and international trial management experience. They have multiple programs ongoing and have a global presence.

    This is a full-time and permanent position. It is office-based in the London with flexibility to work from home (home-based during the pandemic). They offer an excellent salary and package around GBP 70-80K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £50000 - £65000 per annum, bonus + benefits
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    I am partnered with an exciting Pharma client in the London area to help grow their Infectious Disease team.

    This growing Pharmaceutical company works across a range of areas of unmet medical need including Infectious Disease. They are a fantastic organisation who offer excellent development opportunities. Given their success in bringing products to market and rate of growth, this is a rare and exciting proposition. This is working in their Infectious Disease business unit.

    They are recruiting for a Clinical Study Manager to join the team and need an experienced and accomplished Project/Study Manager with international trial management experience. Pharma/Biotech experience is preferred but they will consider people from CRO. Infectious disease or vaccines experience would be a plus but not required.

    This is a full-time and permanent role, it would be home-based initially and they would want someone in the office several days per week post-COVID. The office is based in the London area. There is an excellent salary and package on offer – £50-65K depending on experience + bonus + benefits.

    Skills Alliance are the exclusive partner for this position, please get in touch with Mark Anderson to find out more on +44 207 220 6209 or APPLY NOW.

  • Clinical Operations

    £60000 - £80000 per annum, excellent package
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    A rare opportunity to join a growing early stage Biotech as they build their clinical team. This is a permanent Senior Clinical Study Manager role, mainly home-based with a little travel to the office – Cambs/Herts.

    This exciting and innovative Biotech company are at early stages with trials and just progressing into the clinic. They are expanding at present and will offer great long-term prospects. The company are looking for a very experienced Senior Clinical Study Manager or Senior Clinical Trial Manager, this would be working on complex and fast-paced studies in phase I initially. They require substantial clinical trial management experience, ideally experience in early phase, complex TAs and ideally Biotech experience and/or the ability to work in a fast-paced and ambiguous environment.

    This is a full-time and permanent position. It is mainly home based – going to the office a few days per week. They offer an excellent salary and package around GBP 60-80K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £80000 - £95000 per annum, Excellent package
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    Senior Clin Ops role with an Oncology focussed Biopharma in London. Working at program level and leading their leading programs and line managing a small team.

    This is a rare opportunity to join a reputable Biopharmaceutical company with a great reputation, they have a great pipeline spanning phase I-III and trials being run globally. They are growing and will offer excellent long-term opportunities. We have had excellent feedback from recent placements.

    They are recruiting for a Clinical Program Manager / AD role due to growth and new studies coming up, you would be leading their high profile programs in Oncology and they need a vastly experienced individual, with Oncology trial management and line management experience. They want someone who can work at a senior level and take on a leadership role in the team. It could be haematology or solid tumours.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £80-905K basic salary + bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £75000 - £95000 per annum, Excellent package
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    Global Clinical Program Manager position – purely working in Advanced therapies Oncology. Study responsibility and line management of a small team.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a great pipeline spanning phase I-III and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Global Clinical Program Manager role due to growth, you would be leading their high profile programs in advanced therapies Oncology and they need a vastly experienced individual, with Oncology trial management and line management experience. They want someone who can work at a senior level and take on a leadership role in the team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in the London area. They will offer an excellent salary and package – around £75-95K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Medical Devices

    Competitive
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    Share

    Sind Sie bereit für den nächsten Karriereschritt?

    Derzeit suchen wir für einen Kunden im Raum Stuttgart zum nächstmöglichen Zeitpunkt einen Projektmanager (m/w/d) im Bereich der Medizintechnik. Das mittelständige Unternehmen ist führender Hersteller von aktiven Medizinprodukten, ist mit mehreren Standorten im In- und Ausland vertreten und befindet sich momentan auf Wachstumskurs.

    Das sind Ihre Aufgaben:

    • Planung, Steuerung und Management von Projekten für medizinische Geräte und Konnektivität
    • Leitung mehrerer Produktentwicklungsprojekte in Zusammenarbeit mit
      internationalen Kunden und Lieferanten
    • Unterstützung bei der Projektumsetzung in unseren Produktionsstätten und bei Lieferanten
    • Unterstützung des Key Account Managers in der Anfrage- und Angebotsphase und danach
      Auftragserteilung
    • Enge Zusammenarbeit mit unserem Vertrieb zur Betreuung und Beratung bestehender Kunden
    • Erstellung und laufende Aktualisierung der Ressourcen- und Budgetplanung
    • Sicherstellung der Projektadministration und der regelmäßigen Projektdokumentation
    • Abbildung der Schnittstelle zwischen Entwicklungsabteilung und Kunde

    Das bringen Sie mit:

    • Abgeschlossenes Studium im Bereich der Medizintechnik, des Maschinenbaus, der Elektrotechnik oder eine vergleichbare Qualifikation
    • Ausgeprägte Projektmanagementerfahrung, vorzugsweise in Projektleiterfunktion
    • Idealerweise Projektmanagement-Zertifizierung nach IPMA
    • Erfahrung mit den regulatorischen Anforderungen des Medizinproduktegesetzes, insbesondere
      in Bezug auf den Design Control Prozess
    • Erfahrung mit dem Management von externen Dienstleistern
    • Ausgeprägte Kundenorientierung und Kommunikationsfähigkeit
    • Analytisches Denken und hohes Durchsetzungsvermögen
    • Technisches Verständnis
    • Teamgeist und Motivationsfähigkeit
    • Fließend Deutsch und Englisch in Wort und Schrift

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag unter luis.freitag@skillsalliance.com oder telefonisch unter +496950955657.

  • Medical Devices

    Competitive
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    Share

    Sind Sie bereit für den nächsten Karriereschritt?

    Derzeit suchen wir für einen Kunden im Raum Stuttgart zum nächstmöglichen Zeitpunkt einen Projektleiter Industrial Engineering (m/w/d) im Bereich der Medizintechnik. Das mittelständige Unternehmen ist führender Hersteller von aktiven Medizinprodukten, ist mit mehreren Standorten im In- und Ausland vertreten und befindet sich momentan auf Wachstumskurs.

    Das sind Ihre Aufgaben:

    • Planung und Koordination der Industrialisierungsaktivitäten am Standort in Zusammenarbeit mit internationalen Projektteams
    • Verantwortlich für eine effektive Schnittstelle zwischen Projektmanagement und Industrialisierung unter Berücksichtigung internationaler Projektmanagementstandards
    • Planung, Koordination und Überwachung von Qualifizierungen, Validierungen und Revalidierungen von Fertigungsanlagen, Räumlichkeiten und Prüfverfahren
    • Neuentwicklung und Optimierung von Montage- und Prüfmethoden in Zusammenarbeit mit Produktion, Qualitätsabteilung und Entwicklung
    • Globaler Ansprechpartner für die Implementierung von Testmethoden, Validierungsprozessen und die Überwachung der Prozesskonformität
    • Mitwirkung bei der Einhaltung gesetzlicher Normen und Vorschriften

    Das bringen Sie mit:

    • Erfolgreich abgeschlossenes Ingenieurstudium im Bereich Medizintechnik, Maschinenbau, Verfahrenstechnik o.ä.
    • Einschlägige Berufserfahrung auf dem Gebiet des Industrial Engineering
    • Kenntnisse über relevante Qualitätsstandards, technische Normen und Qualifizierung/Validierung im Bereich der Medizinprodukteindustrie
    • Selbstständige, strukturierte und zielorientierte Arbeitsweise
    • Durchsetzungsvermögen und Teamfähigkeit
    • Gute Kenntnisse der gängigen MS-Office-Produkte
    • Bereitschaft zur Anreise nach Stuttgart an 2 Tagen pro Woche
    • Sehr gute Kenntnisse Deutsch- und Englischkenntnisse in Wort und Schrift

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag unter luis.freitag@skillsalliance.com oder telefonisch unter +496950955657.

  • Medical Devices

    Competitive
    Apply

    Job
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    Share

    Sind Sie bereit für den nächsten Karriereschritt?

    Derzeit suchen wir für einen Kunden am Produktionsstandort im Raum Mosbach zum nächstmöglichen Zeitpunkt einen Projektleiter Industrial Engineering (m/w/d) im Bereich der Medizintechnik. Das mittelständige Unternehmen ist führender Hersteller von aktiven Medizinprodukten, ist mit mehreren Standorten im In- und Ausland vertreten und befindet sich momentan auf Wachstumskurs.

    Das sind Ihre Aufgaben:

    • Planung und Koordination der Industrialisierungsaktivitäten am Standort in Zusammenarbeit mit internationalen Projektteams
    • Verantwortlich für eine effektive Schnittstelle zwischen Projektmanagement und Industrialisierung unter Berücksichtigung internationaler Projektmanagementstandards
    • Planung, Koordination und Überwachung von Qualifizierungen, Validierungen und Revalidierungen von Fertigungsanlagen, Räumlichkeiten und Prüfverfahren
    • Neuentwicklung und Optimierung von Montage- und Prüfmethoden in Zusammenarbeit mit Produktion, Qualitätsabteilung und Entwicklung
    • Globaler Ansprechpartner für die Implementierung von Testmethoden, Validierungsprozessen und die Überwachung der Prozesskonformität
    • Mitwirkung bei der Einhaltung gesetzlicher Normen und Vorschriften

    Das bringen Sie mit:

    • Erfolgreich abgeschlossenes Ingenieurstudium im Bereich Medizintechnik, Maschinenbau, Verfahrenstechnik o.ä.
    • Einschlägige Berufserfahrung auf dem Gebiet des Industrial Engineering
    • Kenntnisse über relevante Qualitätsstandards, technische Normen und Qualifizierung/Validierung im Bereich der Medizinprodukteindustrie
    • Selbstständige, strukturierte und zielorientierte Arbeitsweise
    • Durchsetzungsvermögen und Teamfähigkeit
    • Gute Kenntnisse der gängigen MS-Office-Produkte
    • Bereitschaft zur Anreise an den Produktionsstandort bei Mosbach an 2 Tagen pro Woche
    • Sehr gute Kenntnisse Deutsch- und Englischkenntnisse in Wort und Schrift

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag unter luis.freitag@skillsalliance.com oder telefonisch unter +496950955657.

  • Medical Devices

    Competitive
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    Sind Sie bereit für eine neue Möglichkeit?

    Derzeit suchen wir für einen Kunden am Produktionsstandort im Raum Mosbach zum nächstmöglichen Zeitpunkt einen Techniker Industrial Engineering (m/w/d) im Bereich der Medizintechnik. Das mittelständige Unternehmen ist führender Hersteller von aktiven Medizinprodukten, ist mit mehreren Standorten im In- und Ausland vertreten und befindet sich momentan auf Wachstumskurs.

    Das sind Ihre Aufgaben:

    • Planung und Koordinierung von Industrialisierungsaktivitäten mit Zulieferfirmen und Projektbeteiligten für den lokalen Standort und für internationale Standorte
    • Verantwortung für technische wie mechatronische Neubeschaffung, Optimierungen und Instandsetzungen von Maschinen, Anlagen oder Vorrichtungen für das Produktionsumfeld
    • Entwerfen, Zerspanen und montieren von kleineren Werkzeugen und Vorrichtungen in CAD
    • Erster Ansprechpartner für technische und elektronische Lösungsfindungen
    • Unterstützung bei Qualifikations- und Validierungsaufgaben
    • Mitwirken bei der Einhaltung der gesetzlichen Normen und Vorschriften

    Das bringen Sie mit:

    • Abgeschlossene Ausbildung in der Fachrichtung Mechatronik oder eine vergleichbare Qualifikation
    • Weiterbildung mit einer Techniker-/ Meister-/ Ingenieursausbildung oder einer vergleichbaren Qualifikation ist von Vorteil
    • Offenheit für einschlägige Qualitätsstandards und technischen Normen im Bereich der Medizinprodukteindustrie
    • Erfahrungen aus der Medizintechnik oder artverwandten Bereichen sind von Vorteil
    • Selbstständige, strukturierte und zielorientierte Arbeitsweise
    • Durchsetzungsvermögen und Spaß in der Arbeit im Team
    • Gute MS-Office-, sowie gute CAD-Software-Kenntnisse
    • Sehr gute Englisch- und Deutschkenntnisse in Wort und Schrift

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag unter luis.freitag@skillsalliance.com oder telefonisch unter +496950955657.

  • Quality

    Negotiable
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    Michael Parker at skills alliance is recruiting a QA Officer to specialise in GDP. I am working with one of the largest privately owned import and distribution companies in the UK. They are based in the West Midlands, just outside of Birmingham. They are looking for a several new roles in QA working across both GMP, GDP & QC. Over the pandemic their ability to be nimble has meant they have actually grown and have made several hires in QA this year.

    Overall Objective:
    Provision of QA support for the management and continual improvement of the company QMS, to ensure it meets the requirements of the company licences (including WDA(H)s and MIA), and the relevant parts of GDP and GMP at all times.
    Work effectively with other departments within the business as necessary, to ensure compliance with all relevant company and regulatory standards and maintain the safety, quality and efficacy of all products procured, handled, repackaged and supplied by the company.
    Support other members of the Quality department as necessary.


    Duties and Responsibilities:

    • Support maintenance and continual improvement of the company QMS by preparation, review, approval, training and implementation of SOPs and work instructions, as necessary.
    • Monitor changes in applicable GMP/GDP legislation and guidelines and support implementation of any necessary changes.
    • Identify compliance gaps and make recommendations for continuous improvement.
    • Manage own workload to ensure all tasks are completed within the timelines assigned to meet business needs and customer requirements.
    • Ensure the requirements of applicable product licences (e.g. PLPI, PLGB) are considered and adhered to as necessary.
    • Investigate and report quality incidents, utilising root cause analysis tools as necessary and applying an appropriate risk-based approach. Ensure all quality events and deviations are investigated to an appropriate level and are completed and reported in a timely manner.
    • Propose, implement, and monitor appropriate CAPA plans to address the root cause (or other causal/contributing factors) of non-conformances and ensure the effectiveness of all actions is monitored, as necessary.
    • Investigate and report complaints in a timely manner.
    • Prepare, co-ordinate and manage change controls.
    • Compile and review periodic product quality review reports.
    • Support product recalls where necessary.
    • Perform risk assessments.
    • Perform and report internal and external audits and housekeeping inspections, in accordance with the company audit schedules.
    • Support customer audits and regulatory inspections, as necessary.
    • Document control and archiving-adding new documents to Master Document List, ensure controlled documents are reviewed by periodic review date. Issuing controlled documents and reconcile superseded versions and archiving quality documents.
    • Review QMS documents (e.g. SOPs, work instructions, events, deviations, change controls etc.), ensuring all necessary requirements and standards are considered and approve as necessary.
    • Perform required checks to verify the authenticity of supplied products.
    • Prepare and deliver training, including preparation of training materials and competency assessments.
    • Perform and attend all necessary training and ensure a record of all training is maintained.
    • Perform qualification and/or quality audits and assessments to support approval of suppliers, customers, and service providers.
    • Monitor all suppliers, customers and service providers to ensure they are maintained in a qualified / approved status, taking into account any supply, service or other issues arising during routine use.
    • Generate and review Technical Agreements (TAs) with suppliers, customers and service providers.
    • Monitor the QMS and perform trend analysis. Propose and implement CAPA to address the outcomes from trend analysis as necessary, including potential process efficiency improvements.
    • Provide data, metrics and reports as necessary to monitor the suitability and effectiveness of the QMS. Attend and contribute to Quality Management Review (QMR) meetings. Generate minutes and actions of meetings when required.


    This is an urgent role so for full details please get in contact as soon as possible.


  • Quality

    Negotiable
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    Michael Parker at skills alliance is recruiting a Senior QC Operative. I am working with one of the largest privately owned import and distribution companies in the UK. They are based in the West Midlands, just outside of Birmingham. They are looking for a several new roles in QA working across both GMP, GDP & QC. Over the pandemic their ability to be nimble has meant they have actually grown and have made several hires in QA this year.

    Overall Objective:
    To be efficient in processing the work within the QC Department. Have a good knowledge of and always adhere to the company’s Standard Operating Procedures and comply with both Good Manufacturing Practice and Good Distribution Practice at all times. To comply with all company Health & Safety Policies, Procedures, Work Practices ensuring accuracy and quality and any other Health & Safety requirements at all times.
    __________________________________________________________________________________________
    Duties and Responsibilities:

    • Review and inspect incoming EU deliveries to verify the consignment has been received in an acceptable condition with no visible damages, indication of tampering, and that it is from an approved active supplier. The consignment was shipped securely under acceptable environmental conditions by an approved transport provider. Any products requiring special or secure storage requirements (temperature sensitive stock or controlled drugs) are processed in a timely manner and transferred to the appropriate location.
    • Record all relevant details of deliveries received on the company system.
    • Performing identity checks on raw product and reporting any discrepancies with the associated specification.
    • Ensuring all checks are recorded accurately during identification check.
    • Ensuring photographs of raw product are taken showing all faces (outer and inner) with batch number, expiry date and EU/ECMA visible and attached to batch documentation.
    • Ensuring all Italian sourced consignments undergo a Bollino authenticity check.
    • Ensuring all Greek sourced stock undergoes a Vignette authenticity check.
    • In process checks during production.
    • Performing a line clearance prior to and post QC final verification checks and completing the line clearance logbook accordingly.
    • Ensuring all relevant documentation is present with the working BPR and confirmed as complete.
    • Inspect materials or products being produced and recording outcomes in the relevant documentation.
    • Compering materials or products against a pre-defined standard specification.
    • Approving or rejecting components, packaging materials and finished products.
    • Ensure that if errors occurred, that they have been reported.
    • Check performs on the pre-printed packaging materials:
    • Removing and checking number of samples specified in the sampling plan for packaging material (number of samples is determined by QA personnel).
    • Escalating any quality defects to the QA who will assess the conformance or non-conformance of packaging material.
    • Performing identification check on the random sample that represents the batch; if any discrepancies related to the starting material or/and finished product found at this point, QC quarantines the whole unit.
    • Reviewing the batch records and ensuring all entries are inserted accurately.

    Support QC Manager:

    • Ensuring QC staff always comply with the applicable GMP requirements and associated processes and procedures.
    • Reporting any errors/non-compliances as quality incidents. Ensuring the details of any events or deviations raised are accurately recorded in the applicable controlled document (including the corresponding references).
    • Informing the operations manager of product related quality incidents as soon as possible.
    • Escalating any issues or concerns to The Quality Director, GMP QA Manager or RP.
    • Provide advice to staff regarding the quality standards.
    • Monitor operations to ensure compliance with quality standards.
    • Providing assistance to production staff where necessary regarding the quality standards.
    • Ensuring all retention samples are stored securely.
    • Ensuring all completed and signed batch records are stored securely.
    • Monitoring retention periods for batch documentation and retention samples.


    This is an urgent role so please get in touch as soon as possible if you are interested.

  • Clinical Development

    £65000 - £78000 per annum, Bonus + benefits + shares
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    Great opportunity for an experienced Study Manager or Senior Study Manager to join a niche Biotech working in advanced therapies. The role is permanent and the office is based in Central London (with flexibility).

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research and we have had great feedback from recent placements.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable and global experience. It is a great opportunity to gain gene therapy/advanced therapies experience.

    This is a permanent and full-time role. The role would be home-based initially with travel to the Central London office. They offer an excellent salary – GBP 65,000-78,000 + bonus + benefits + shares.

    Skills Alliance are the exclusive partner for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Development

    £65000 - £80000 per annum, Bonus + benefits
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    *PHARMA/CRO EXPERIENCE REQUIRED*

    Rare and exclusive opportunity to join a small CRO, it is a Senior Project Manager role which can be home-based across the UK.

    This small organisation are well established and have a global presence with offices in Europe and the US. They have a friendly and family feel to the organisation and offer excellent flexibility and work life balance. This CRO has a strong reputation in the market and are well known in the niche that they work in. We have had great feedback from recent placements.

    The Senior Project Manager will be responsible for managing a full-service global trial in Neurodegeneration – they also have studies coming up in Oncology. They need a strong Senior PM candidate with CRO experience, EU trial management, phase II and III and budget management are essential. Experience of bid defenses and in Neuroscience are preferred. In return, the individual will be well rewarded with excellent flexibility and a strong package.

    This is a permanent and full-time role. They have an office in the South East but everyone is now home-based and this can be a remote role across the UK. They will offer a very good salary around £65-80K depending on experience + bonus + benefits.

    Skills Alliance are the exclusive partner for this new Senior PM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £55000 - £70000 per annum, Excellent package
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    Clinical Study Manager position – purely working in their Inflammation team.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a wide-ranging pipeline spanning phase I-III (and late phase) and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in growth at present and we have had excellent feedback from previous placements.

    They are recruiting for a Clinical Study Manager / Clinical Trial Manager role due to growth and new studies coming up, they will offer excellent progression opportunities, with rapid promotion prospects possible for high performing individuals. You would be managing their high profile programs in Inflammation and they need a an experienced individual, with EU trial management, ideally in phase II and III.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £55-70K basic salary + excellent bonus + benefits.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £40000 - £45000 per annum
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    An opportunity to join a unique and very well-funded vaccine organisation, with offices in London, with a company who are doing very interesting work to overcome COVID and other infectious diseases.

    This is an opportunity to really have an impact on the global society, within a copany who are expanding rapidly, They are looking to build out the organisation and are looking for high calibre candidates who want to make a difference.

    They are looking for a Project Coordinator who:

    • Can support the Project Management team
    • Has significant CTA/project coordination experience
    • Has good scientific knowledge, a life sciences degree is desireable
    • Is a self-starter who can work in a fast-paced, small and ambiguous environment
    • Is comfortable working with senior level stakeholders and new and existing clients
    • Has experience overseeing clinical trials across phases I-III

    It is full-time and permanent Role, which can be office-based in London or home-based with occasional travel to the office. They will offer a very good salary – £40-45K + excellent benefits.

    Skills Alliance are the preferred supplier for this role. Please contact Matt Askew for more details on +44 2045 1315 49 (1068) or click APPLY NOW.

  • Clinical Operations

    £45000 - £55000 per annum
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    This is a great opportunity to join a growing CRO who are niche and have a strong reputation, working in a range of therapy areas including Oncology and Rare Disease across phases I-IV,

    The innovative company has a rare opportunity to work as a Senior CRA with minimal on site monitoring, whilst also having the potential to take on lead responsibilities, in a small but growing team,

    Specific Job Duties:
    • Primarily remote monitoring with occasional site visit
    • Monitor the progress of reports to the local ethics committee and other regulatory
    applications, including online submissions for Global studies
    • Contract and budget negotiation with relevant departments
    • Study feasibility assessments

    Requirements:
    • Mandatory Life Science background (Degree is desireable) or equivalent years of industry
    and monitoring experience
    • Minimal travelling– approximately 10% depending on study

    Additional Responsibilities:
    • Mentoring new and/or junior CRAs

    It is full-time and permanent Role, which is primarily home-based with minimal travel to sites. They will offer a very good salary – £45-55K + excellent benefits.

    Skills Alliance are the preferred supplier for this role. Please contact Matt Askew for more details on +44 2045 1315 49 (1068) or click APPLY NOW.

  • Clinical Operations

    £65000 - £75000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative vaccine organisation. They are hiring for multiple PMs due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Senior Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous cross-functional project management experience, ideally managing projects from phase I-III. They will consider experienced PMs from Pharma, Biotech or CRO and vaccines experience would be a strong preference. The feedback from recent placements has been outstanding.

    This is a full-time and permanent position to be home-based with infrequent travel to their offices in Central London when normality resumes. They will offer a very competitive salary – circa £65-£75K depending on experience + full benefits package.

    Skills Alliance are the exclusive partner for this role, please get in contact with Mark Anderson for more details – +44 207 220 6209.

  • Project Management

    £60000 - £75000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative vaccine organisation. They are hiring for multiple PMs due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Senior Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous cross-functional project management experience, ideally managing projects from phase I-III. They will consider experienced PMs from Pharma, Biotech or CRO and vaccines experience would be a strong preference. The feedback from recent placements has been outstanding.

    This is a full-time and permanent position to be home-based with infrequent travel to their offices in Central London when normality resumes. They will offer a very competitive salary – circa £60-£75K depending on experience + full benefits package.

    Skills Alliance are the exclusive partner for this role, please get in contact with Mark Anderson for more details – +44 207 220 6209.

  • Clinical Development

    £65000 - £75000 per annum, Excellent package
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    Senior Global Clinical Study Manager position – purely working in Oncology, could be solid tumours, haematology or advanced therapies. Study responsibility and line management of a small team.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a wide-ranging pipeline spanning phase I-III (and late phase) and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Senior Clinical Study Manager / Senior Global Trial Manager role due to growth and new studies coming up, you would be leading their high profile programs in Oncology and they need a an experienced individual, with Oncology trial management and ideally line management experience. They want someone who can work at a senior level and take on a leadership role in the team. It could be or solid tumours, haematology or in their cell & gene therapy team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £65-75K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £55000 - £70000 per annum, Excellent package
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    Clinical Study Manager position – purely working in Oncology, could be solid tumours, haematology or advanced therapies.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a wide-ranging pipeline spanning phase I-III (and late phase) and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Clinical Study Manager / Clinical Trial Manager role due to growth and new studies coming up, you would be managing their high profile programs in Oncology and they need a an experienced individual, with Oncology trial management. It could be or solid tumours, haematology or in their cell & gene therapy team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £55-70K basic salary + excellent bonus + benefits.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Pre-Clinical

    £55000 - £65000 per annum, Excellent package
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    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management / PMO team. The company work in a cutting edge area in the advanced therapies space and have won numerous awards recently for innovation, they are growing rapidly. It is a fantastic time to join and there will be great long-term opportunities.

    The role will support the PM group to deliver a range of interesting projects and it will work closely with Scientific teams. They are looking for someone at Senior R&D PM level who has strong Pharma/Biotech experience ideally in cell or gene therapy – ideally experience of Agile methodologies. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to be based in their Cambridge office (with flexibility to WFH 2-3 days). They will offer circa £55-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this Senior Project Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Clinical Operations

    £55000 - £65000 per annum, bonus + shares + benefits
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    (SENIOR) CLINICAL STUDY MANAGER – BIOTECH – HOME-BASED ACROSS UK – PERMANENT (BONUS + SHARES)

    I am partnered with a small and fast growing early phase Biotech based at present who are recruiting for an Early Phase Clinical Study Manager or Senior Clinical Study Manager.

    This is a rare opportunity to join a small Biotech, they are moving into the clinic with their first studies and they need an experienced and autonomous Clinical Trial Manager or Senior Clinical Trial Manager who has worked in Pharma or Biotech previously and managed phase I studies.

    They are working on interesting studies in an exciting therapeutic area and have a platform that can be applied to a range of further TAs in the future. Naturally it is a great time to join as they have doubled in size in the past year.

    The position is permanent, full-time and home-based unless attending important meetings in the office. They will offer an excellent salary – circa £55-65K + bonus + share options + benefits.

    Skills Alliance are the exclusive partner for this position. Please get in contact with Mark Anderson for more details – mark.anderson@skillsalliance.com

  • Clinical Operations

    £45000 - £55000 per annum, Benefits + Bonus
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    SENIOR CLINICAL RESEARCH ASSOCIATE

    A rare opportunity to join a SME CRO who are niche company and have a strong reputation. This is a permanent Senior Clinical Research Associate role with minimal on-site monitoring. They work in a range of life-threatening areas such as Oncology, and rare disease. Working across phases I-IV.
    This is an exciting opportunity to join a growing company. As they expand there will be excellent opportunities for progression and development. This is a wide-ranging role, which will include taking on lead responsibilities. The company is looking for someone with CRA experience, start-up and submissions experience and contract negotiation experience would be beneficial.

    Responsibilities:

    • On site and remote monitoring visits.
    • Good knowledge of UK legislation in relation to clinical trials/observational studies.
    • Site contract and budget negotiation with local R&D Departments and Hospitals.
    • Preparation and submission of local ethics and regulatory applications.
    • Performing feasibility assessments.
    • Serve as a mentor for new/junior CRAs


    Requirements:

    • Bachelor’s degree – mandatory Life Science background or industry experience.
    • Experience in electronic Etmf, CTMS, EDC
    • Minimal travel – depending on study allocation.


    This is a home-based role with minimal on-site monitoring – only 1 day per month on average. It is a permanent role offering around £45-55K + bonus + benefits.

    Skills Alliance are the preferred supplier for this SCRA role. Please contact Shannon Summers for more details on 020 4513 1552 or click APPLY NOW.

  • Clinical Operations

    £40000 - £45000 per annum, Benefits
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    PROJECT COORDINATOR

    A unique opportunity to join an innovative, not for profit vaccine organisation. The organisation is partnered with Pharmas and Biotechs to overcome epidemic outbreaks such a COVID and other infectious diseases. They have a unique approach and will have a direct impact on global epidemics in the coming years.

    With this goal in mind, they are looking for high calibre candidates who want to make a difference.

    Responsibilities:

    • The Project Coordinator will support the successful delivery of several vaccine R&D projects associated with the organisations mission.
    • Working in close collaboration and supporting the PMs
    • Opportunity to progress into a PM role in the long-term.

    Requirements:

    • Ideally someone who has a good scientific knowledge, a life sciences degree.
    • Previous CTA or Project Coordinator experience.
    • Ability to work in a fast-paced environment.


    This is a home-based role with occasional travel to the offices in Central London. It is a full-time and permanent role offering a competitive salary around £40-45K + full benefits.

    Skills Alliance are the preferred supplier for this Project Coordinator role. Please contact Shannon Summers for more details on 020 4513 1552 or click APPLY NOW.

  • Quality

    Competitive
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    Neue Möglichkeit in Berlin!

    Wir suchen derzeit für einen Kunden einen Quality Manager (m/w/d). Das Unternehmen aus Berlin, das onkologische Medizinprodukte entwickelt und produziert, besteht aus knapp 80 Mitarbeitern und hat aktuell neun verschiedene Produkte im Angebot. In seinem Tätigkeitsbereich ist das Unternehmen Vorreiter und aufgrund seiner innovativen Asurichtung in diesem Bereiche ebenfalls Marktführer. Neben einer attraktiven Vergütung und einer sehr guten digitalen Infrastruktur für Remote-Lösungen werden außerdem weitere Benefits geboten.

    Das sind Ihre Aufgaben:

    • Unterstützung des QMR bei der Entwicklung und Pflege des QMS
    • Unterstützung des QMS-Digitalisierungsprojekts (papierloses Dokumentenmanagement- und Schulungsmanagementsystem) durch Sicherstellung der Einhaltung der geltenden EN ISO 13485 und MDR 2017/745 Anforderungen
    • Unterstützung des RA-Teams und des Produktmanagement-Teams bei der Entwicklung von Device Technical Files in Übereinstimmung mit den geltenden Anforderungen
    • Organisation von Audittätigkeiten im Unternehmen und allen dazugehörigen Unterorganisationen
    • Unterstützung bei der Integration und Konsolidierung von QM-Prozessen zur Sicherstellung der Q&R-Prozessstruktur
    • Leitung und Moderation von NCR- & CAPA-Meetings zur Lösung von Abweichungen/Problemen, die aus internen und externen Quellen gemeldet werden
    • Handhabung und Koordinierung der Änderungen, die sich aus dem Änderungskontrollprozess ergeben, durch Sicherstellung der Stabilität und Robustheit des QMS
    • Leitung der Validierungsaktivitäten für Computersysteme und Unterstützung der Validierungsaktivitäten am Standort Berlin. Außerdem ist der-/diejenige für die Leitung des QA-Validierungsingenieurs verantwortlich.
    • Abbildung von QMS-Prozessen zur Identifizierung von Lücken, Schleifen und Verbesserungsbereichen
    • Förderung der kontinuierlichen Verbesserung bestehender QMS-Prozesse und Unterstützung der Prozessverantwortlichen bei der Implementierung schlanker QMS-Prozesse
    • Führen des PFMEA-Risikoregisters und Unterstützung des Risikomanagers und des PRRCs bei Aktivitäten zur Einhaltung der EN ISO 14971
    • Vorantreiben von Aktivitäten zur Optimierung der Lieferkette für Prozesse im Zusammenhang mit der Produktrealisierung
    • Durchführung von QM-Basistrainings für das Onboarding neuer Mitarbeiter

    Das bringen Sie mit:

    • Mindestens 3 bis 5 Jahre Berufserfahrung in einer Qualitäts- und Regulatory-Funktion in einem Unternehmen für Medizinprodukte
    • Idealerweise Arbeitserfahrung mit aktiven Medizinprodukten
    • Kenntnisse der DIN EN ISO 13485:2016, MDR 2017/745, EN 14971:2020, EN 60601 sind erforderlich. 21CFR Part 820 und MDSAP Kenntnisse sind wünschenswert.
    • Einschlägige Arbeitserfahrung mit Microsoft Office 365 Paket-Tools
    • Kenntnisse der CAPA-Behandlung auf der Grundlage des 8-D-Prozesses und verschiedener Methoden der Ursachenanalyse
    • Kenntnisse der Prozessabbildung (idealerweise auf Basis von Microsoft Visio) und des Verständnisses von Verbesserungsbereichen
    • Kenntnisse in Kaizen; Lean Six-Sigma ist ein Plus
    • Ausgezeichnete Deutsch- (mindestens C1) und Englischkenntnisse in Wort und Schrift

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag unter luis.freitag@skillsalliance.com oder telefonisch unter +496950955657.

  • Clinical Operations

    £60000 - £78000 per annum, excellent package
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    A rare opportunity to join a growing Gene Therapies focussed Biotech. This is a permanent Senior Clinical Study Manager role based in Central London.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They are expanding at present and will offer great long-term prospects. The company are looking for a very experienced Senior Clinical Study Manager or Senior Clinical Trial Manager, this would be working on complex and fast-paced studies from phase I-III. They require substantial clinical trial management experience, ideally experience in early phase, complex TAs and international trial management experience. They have multiple programs ongoing and have a global presence.

    This is a full-time and permanent position. It is office-based in the London with flexibility to work from home (home-based during the pandemic). They offer an excellent salary and package around GBP 70-80K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £60000 - £80000 per annum, excellent package
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    A rare opportunity to join a growing early stage Biotech as they build their clinical team. This is a permanent Senior Clinical Study Manager role, mainly home-based with a little travel to the office – Cambs/Herts.

    This exciting and innovative Biotech company are at early stages with trials and just progressing into the clinic. They are expanding at present and will offer great long-term prospects. The company are looking for a very experienced Senior Clinical Study Manager or Senior Clinical Trial Manager, this would be working on complex and fast-paced studies in phase I initially. They require substantial clinical trial management experience, ideally experience in early phase, complex TAs and ideally Biotech experience and/or the ability to work in a fast-paced and ambiguous environment.

    This is a full-time and permanent position. It is mainly home based – going to the office a few days per week. They offer an excellent salary and package around GBP 60-80K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £80000 - £95000 per annum, Excellent package
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    Senior Clin Ops role with an Oncology focussed Biopharma in London. Working at program level and leading their leading programs and line managing a small team.

    This is a rare opportunity to join a reputable Biopharmaceutical company with a great reputation, they have a great pipeline spanning phase I-III and trials being run globally. They are growing and will offer excellent long-term opportunities. We have had excellent feedback from recent placements.

    They are recruiting for a Clinical Program Manager / AD role due to growth and new studies coming up, you would be leading their high profile programs in Oncology and they need a vastly experienced individual, with Oncology trial management and line management experience. They want someone who can work at a senior level and take on a leadership role in the team. It could be haematology or solid tumours.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £80-905K basic salary + bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £75000 - £95000 per annum, Excellent package
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    Global Clinical Program Manager position – purely working in Advanced therapies Oncology. Study responsibility and line management of a small team.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a great pipeline spanning phase I-III and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Global Clinical Program Manager role due to growth, you would be leading their high profile programs in advanced therapies Oncology and they need a vastly experienced individual, with Oncology trial management and line management experience. They want someone who can work at a senior level and take on a leadership role in the team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in the London area. They will offer an excellent salary and package – around £75-95K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £50000 - £65000 per annum, +Bonus +Benefits
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    Skills Alliance have an incredible opportunity to join a well established, niche, full service CRO, who SPECIALISE in Oncology trials on an international scale, working across both early and late phases.

    They are currently recruiting for a Clinical Project Manager to oversee ONCOLOGY clinical trials and to be the first point of call for Sponsors and Vendors, from start up through to close OUT of GLOBAL studies.

    Specific Job Duties:

    • Manage budgets throughout clinical trials and ensure they are kept within the agreed range and scope
    • Develop specific study plans and ensure they are adheared to
    • Manage the CTMF and study documentation
    • Oversee the full life-cycle of the trial ensuring all enquries are answered and any issues are resolved
    • Ensure risk and mitigations are identified and communicated with study teams

    Requirements:

    • A Life Sciences Background (Degree is desireable) or Relevant years in the industry
    • Cross-functional/Full-service PM experience
    • Experience in Trial/Project Management in Oncology studies
    • Pharmaceutical/CRO experience (Preffered)

    This is a full-time and permanent role, working remotely. Offering a very good salary – £50-£65k + Bonus + Benefits.
    Skills Alliance are the preferred supplier for this role. Please contact Matt Askew for more details via matthew.askew@skillsalliance.com or click APPLY NOW.

  • Clinical Operations

    £50000 - £65000 per annum, bonus + benefits
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    CLINICAL PROJECT MANAGER

    A rare opportunity to join a full service CRO who are niche company and have a strong reputation. This is permanent Clinical Project Manager role. Their main focus is working within Oncology, working across phases I-III. This is an exciting opportunity to join a growing company. As they expand there will be excellent opportunities for progression and development. This is a wide-ranging role, which will include being a primary point of contact, working directly with cross functional teams, sponsors and vendors.

    Responsibilities:

    • Working on global studies from start up to close out.
    • Proactive management of study timelines and budgets.
    • Identify and evaluate risks, establish solutions.
    • Ensuring projects are delivered to quality standards.
    • Provide management, training, support and guidance to the study team.


    Requirements:

    • Bachelors degree – preferably in the life sciences field.
    • Cross-functional / Full-service project management experience.
    • Prior experience with Biotech/Pharma or CRO environment.
    • Oncology experience strongly preferred.


    This is a fully home-based role. It is a full time and permanent role offering a competitive salary around £50-65K + bonus + benefits.

    Skills Alliance are the preferred supplier for this CPM role. Please contact Shannon Summers for more details on shannon.summers@skillsalliance.com or click APPLY NOW.

  • Clinical Operations

    £45000 - £55000 per annum, + Benefits
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    This is a great opportunity to join a growing CRO who are niche and have a strong reputation, working in a range of therapy areas including Oncology and Rare Disease across phases I-IV,

    The innovative company has a rare opportunity to work as a Senior CRA with minimal on site monitoring, whilst also having the potential to take on lead responsibilities, in a small but growing team,

    Specific Job Duties:
    • Primarily remote monitoring with occasional site visit
    • Monitor the progress of reports to the local ethics committee and other regulatory
    applications, including online submissions for Global studies
    • Contract and budget negotiation with relevant departments
    • Study feasibility assessments

    Requirements:
    • Mandatory Life Science background (Degree is desireable) or equivalent years of industry
    and monitoring experience
    • Minimal travelling– approximately 10% depending on study

    Additional Responsibilities:
    • Mentoring new and/or junior CRAs

    It is full-time and permanent Role, which is primarily home-based with minimal travel to sites. They will offer a very good salary – £45-55K + excellent benefits.

    Skills Alliance are the preferred supplier for this role. Please contact Matt Askew for more details via matthew.askew@SkillsAlliance.com or click APPLY NOW.

  • Clinical Operations

    £65000 - £80000 per annum, + Bonus + Benefits
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    Skills Alliance have an incredible opportunity to join a well established, niche, full service CRO, who SPECIALISE in Oncology trials on an international scale, working across both early and late phases.

    They are currently recruiting for a Senior Clinical Project Manager to oversee ONCOLOGY clinical trials and to be the first point of call for Sponsors and Vendors, from start up through to close OUT of GLOBAL studies.

    Specific Job Duties:

    • Manage budgets throughout clinical trials and ensure they are kept within the agreed range and scope
    • Sign off and implament specific study plans and ensure they are adheared to
    • Oversee CPMs and a team of study leaders in a clincial operation
    • Manage the CTMF and study documentation
    • Oversee the full life-cycle of the trial ensuring all enquries are answered and any issues are resolved
    • Ensure risk and mitigations are identified and communicated with study teams

    Requirements:

    • A Life Sciences Background (Degree is desireable) or Relevant years in the industry
    • Cross-functional/Full-service PM experience
    • Line Management experience (Preffered)
    • Experience in Trial/Project Management in Oncology studies
    • Pharmaceutical/CRO experience (Preffered)

    This is a full-time and permanent role, working remotely. Offering a very good salary – £65-£80K+ Bonus + Benefits.
    Skills Alliance are the preferred supplier for this role. Please contact Matt Askew for more details via matthew.askew@skillsalliance.com or click APPLY NOW.

  • Clinical Operations

    £65 - £80 per annum, bonus + benefits
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    SENIOR CLINICAL PROJECT MANAGER

    A rare opportunity to join a full service CRO who are niche company and have a strong reputation. This is permanent Senior Clinical Project Manager role. Their main focus is working within Oncology, working across phases I-III. This is an exciting opportunity to join a growing company. As they expand there will be excellent opportunities for progression and development. This is a wide-ranging role, which will include being a primary point of contact, working directly with cross functional teams, sponsors and vendors.

    Responsibilities:

    • Working on global studies from start up to close out.
    • Proactive management of study timelines and budgets.
    • Identify and evaluate risks, establish solutions.
    • Ensuring projects are delivered to quality standards.
    • Provide management, training, support and guidance to the study team.


    Requirements:

    • Bachelors degree – preferably in the life sciences field.
    • Cross-functional / Full-service project management experience.
    • Prior experience with Biotech/Pharma or CRO environment.
    • Oncology experience strongly preferred.


    This is a fully home-based role. It is a full time and permanent role offering a competitive salary around £65-80K + bonus + benefits.

    Skills Alliance are the preferred supplier for this Senior CPM role. Please contact Shannon Summers for more details on shannon.summers@skillsalliance.com or click APPLY NOW.

  • Pre-Clinical

    £50000 - £65000 per annum, Excellent package
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    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management team. The company are highly innovative and work in a new and exciting area in advanced therapies, they have some exciting partnerships established and are growing rapidly. It is a fanastic time to join and they have a great team in place and is working at the cutting edge of advanced therapies.

    The role will support the PMO to deliver pre-clinical development projects and work closely with the R&D team. They are looking for someone at R&D PM level who has strong Pharma/Biotech experience ideally within pre-clinical – ideally MS Project experience and a PRINCE2 or similar PM qualification would be a plus too. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to go into the Oxford office when normality resumes (with flexibility to WFH 2-3 days). They will offer circa £50-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this R&D Proejct Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Clinical Operations

    £60000 - £80000 per annum, Bonus + benefits
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    *PHARMA/CRO EXPERIENCE REQUIRED*

    A great opportunity to join a medium-sized CRO with a great culture and low turnover. They are recruiting for PM and Senior PM roles due to organic growth and new studies.

    This company have a great track record and have been very successful during COVID where other CROs have struggled. They are a SME CRO who are dynamic and work in very interesting and complex therapy areas. Studies span phases I-IV and they work in Oncology and Gene Therapy amongst other areas.

    They are recruiting for multiple roles due to new studies coming in and they need an experienced cross-functional PM who has budget management experience. It could be working on a range of studies and would be working globally. There are also opportunities to progress quickly.

    This is a permanent and full-time role. They have an office in the South East but everyone is now home-based and this can be a remote role across the UK. They will offer a very good salary – GBP 60-80K + bonus + benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Pre-Clinical

    £55000 - £65000 per annum, Excellent package
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    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management / PMO team. The company work in a cutting edge area in the advanced therapies space and have won numerous awards recently for innovation, they are growing rapidly. It is a fantastic time to join and there will be great long-term opportunities.

    The role will support the PM group to deliver a range of interesting projects and it will work closely with Scientific teams. They are looking for someone at R&D PM level who has strong Pharma/Biotech experience ideally in stem cells or gene therapy – ideally experience of Agile methodologies. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to be based in their Cambridge office (with flexibility to WFH 2-3 days). They will offer circa £55-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this Senior Project Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Project Management

    £60000 - £75000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative vaccine organisation. They are hiring for multiple PMs due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Senior Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous cross-functional project management experience, ideally managing projects from phase I-III. They will consider experienced PMs from Pharma, Biotech or CRO and vaccines experience would be a strong preference. The feedback from recent placements has been outstanding.

    This is a full-time and permanent position to be home-based with infrequent travel to their offices in Central London when normality resumes. They will offer a very competitive salary – circa £60-£75K depending on experience + full benefits package.

    Skills Alliance are the exclusive partner for this role, please get in contact with Mark Anderson for more details – +44 207 220 6209.

  • Clinical Operations

    £65000 - £75000 per annum, Excellent package
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    Share

    Skills Alliance are retained on a unique opportunity with an innovative vaccine organisation. They are hiring for multiple PMs due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Senior Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous cross-functional project management experience, ideally managing projects from phase I-III. They will consider experienced PMs from Pharma, Biotech or CRO and vaccines experience would be a strong preference. The feedback from recent placements has been outstanding.

    This is a full-time and permanent position to be home-based with infrequent travel to their offices in Central London when normality resumes. They will offer a very competitive salary – circa £65-£75K depending on experience + full benefits package.

    Skills Alliance are the exclusive partner for this role, please get in contact with Mark Anderson for more details – +44 207 220 6209.

  • Clinical Development

    £65000 - £75000 per annum, Excellent package
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    Senior Global Clinical Study Manager position – purely working in Oncology, which could be in solid tumours, haematology or advanced therapies.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a wide-ranging pipeline spanning phase I-III (and late phase) and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Senior Clinical Study Manager / Senior Global Trial Manager role due to growth and new studies coming up, you would be leading their high profile programs in Oncology and they need a an experienced individual, with Oncology trial management and ideally line management experience. They want someone who can work at a senior level and take on a leadership role in the team. It could be or solid tumours, haematology or in their cell & gene therapy team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £65-75K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £65000 - £90000 per annum, 20% bonus + benefits
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    Great opportunity for an experienced Snr Clinical Project Manager or Clinical Program Manager/AD to join a niche Bitoech working in Oncology. The role is based in Central London with good flexibility.

    The role is with a niche and unique Biotech who are very innovative and work specifically in the Oncology field. The company is growing quickly and have a number of Oncology assets in pre-clinical and early phase trials. This would be working at the cutting edge of research with a great team who are looking to make a real impact on patients’ lives.

    You would be the asset lead for one of their early phase compounds, working on a cross-functional basis and getting involved in a very wide range of activities from protocol writing and development to CRO and vendor selection, working on phase I and II studies. They work in a range of areas in Oncology.

    This is a permanent and full-time role. The role is based in London but there is flexibility to work from home. They offer an excellent salary in the region of £65-90K depending on expeirence + 20% bonus + benefits + possibly options.

    Skills Alliance are the exclusive partner for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click “APPLY NOW”.

  • Clinical Operations

    £55000 - £75000 per annum, bonus + shares + benefits
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    (SENIOR) CLINICAL STUDY MANAGER – BIOTECH – HOME-BASED ACROSS UK – PERMANENT (BONUS + SHARES)

    I am partnered with a small and fast growing early phase Biotech based at present who are recruiting for an Early Phase Clinical Study Manager or Senior Clinical Study Manager.

    This is a rare opportunity to join a small Biotech, they are moving into the clinic with their first studies and they need an experienced and autonomous Clinical Trial Manager or Senior Clinical Trial Manager who has worked in Pharma or Biotech previously and managed phase I studies.

    They are working on interesting studies in an exciting therapeutic area and have a platform that can be applied to a range of further TAs in the future. Naturally it is a great time to join as they have doubled in size in the past year.

    The position is permanent, full-time and home-based unless attending important meetings in the office. They will offer an excellent salary – circa £55-75K + bonus + share options + benefits.

    Skills Alliance are the exclusive partner for this position. Please get in contact with Mark Anderson for more details – mark.anderson@skillsalliance.com

  • Pre-Clinical

    £55000 - £65000 per annum, Excellent package
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    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management / PMO team. The company work in a cutting edge area in the advanced therapies space and have won numerous awards recently for innovation, they are growing rapidly. It is a fantastic time to join and there will be great long-term opportunities.

    The role will support the PM group to deliver a range of interesting projects and it will work closely with Scientific teams. They are looking for someone at Senior R&D PM level who has strong Pharma/Biotech experience ideally in cell or gene therapy – ideally experience of Agile methodologies. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to be based in their Cambridge office (with flexibility to WFH 2-3 days). They will offer circa £55-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this Senior Project Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Project Management

    Competitive
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    Sind Sie bereit für den nächsten Karriereschritt?

    Derzeit suchen wir für einen Kunden, einen branchenübergreifenden internationalen Technologiekonzern mit ca. 10.000 Mitarbeitern an mehr als 100 Standorten weltweit, einen Senior QCV-Engineer (m/w/d), welcher die Führung und Weiterbildung eines Projektteams übernehmen soll.

    Das sind Ihre Aufgaben:

    • Leitung und Schulung von jüngeren Teammitgliedern
    • Selbstständige Leitung von Projekten und gleichzeitige Steuerung und Überwachung von Aktivitäten, Fristen, Kapazitätsplanung
    • Verfassen und Überprüfen von GMP/GDP-Dokumenten und technischen Spezifikationen
    • Initiierung und Koordinierung von Risikoanalysen, Entwurfsprüfungen, Durchführung von FAT/ SAT
    • Funktion als primärer Experte für Inbetriebnahme und Validierung für bestimmte Projekte gemäß den Grundsätzen und Normen der ASTM E2500
    • Leitung und Beteiligung an der Entwicklung und Durchführung der vollständigen Verifizierungs-/Validierungsdokumentation
    • Dokumentation in Übereinstimmung mit Qualitätsstandards, cGMP-Anforderungen und genehmigten Verifizierungsanforderungen in Bezug auf die zugewiesenen Arbeitsabläufe
    • Effektive Interaktion und Zusammenarbeit mit der globalen Leitung, dem technischen Projektmanagement, der Automatisierung, Wartung, Produktion und dem Qualitätsmanagement, um effiziente Qualifizierungspläne beim Kunden zu erstellen
    • Weiterverfolgung und Koordinierung der Inbetriebnahme- und Qualifizierungsaktivitäten zwischen den Projektteams, Lieferanten/Auftragnehmern und Start-Up-Teams
    • Durchführung/Leitung der wöchentlichen C&Q-Sitzungen, um einen Überblick über die laufenden Inbetriebnahme- und Validierungsaktivitäten zu geben
    • Koordinierung aller Aktivitäten vor der Inbetriebnahme zwischen mehreren Parteien

    Das bringen Sie mit:

    • Bachelor-/Master-Abschluss in Elektromechanik (bevorzugt), Chemieingenieurwesen, Maschinenbau oder biopharmazeutischem Ingenieurwesen
    • Mindestens 10 Jahre Berufserfahrung und Kenntnisse in Bezug auf mechanische Anlagen, sowie Erfahrung in der Arbeit mit HMI, SCADA, PLC, RTU und DCS
    • Erfahrung mit Abfüllmaschinen, Gefriertrocknung, Verpackungs- und Inspektionsmaschinen sowie mit gebäudebezogenen Elementen wie WFI, HVAC, Reinräumen, Versorgungseinrichtungen, usw.
    • Umfassendes Verständnis der GMP-Richtlinien und praktische Erfahrungen in den Produktionsbereichen von USP und DSP, einschließlich der Abfüll- und Verpackungsbereiche
    • Umfassendes Verständnis von cGMPs und GDP, den ASTM E2500-07 Prinzipien, sowie den ISPE und GAMP®5 Richtlinien
    • Verständnis der internationalen regulatorischen Anforderungen wie FDA, EMA und ICH
    • Kenntnisse des pharmazeutischen Prozesses von Anlagensystemen (Benutzeranforderungen, Design, Wartung)
    • Arbeitskenntnisse im Bereich Bioprozess-SU (Einmalgebrauch) und konventionellem SS (Edelstahl) bei der Herstellung von biopharmazeutischen Produkten wie mAb und Impfstoffen sind von Vorteil
    • Gute analytische und organisatorische Fähigkeiten, Zeitmanagement und Problemlösungsfähigkeit
    • Teamfähigkeit und professionelle Englisch- und Deutschkenntnisse in Wort und Schrift
    • Erfahrung im Projektmanagement und dem Umgang mit MS Project
    • Nachweisliches Verständnis des risikobasierten Ansatzes bei der Inbetriebnahme und Qualifizierung
    • Bereitschaft im In- und Ausland zu reisen, mit mehrtägigen Aufenthalten am Einsatzort, sowie remote zu Arbeiten

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag unter luis.freitag@skillsalliance.com oder telefonisch unter +496950955657.

  • Clinical Operations

    £65000 - £75000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative vaccine organisation. They are hiring for multiple PMs due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Senior Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous cross-functional project management experience, ideally managing projects from phase I-III. They will consider experienced PMs from Pharma, Biotech or CRO and vaccines experience would be a strong preference. The feedback from recent placements has been outstanding.

    This is a full-time and permanent position to be home-based with infrequent travel to their offices in Central London when normality resumes. They will offer a very competitive salary – circa £65-£75K depending on experience + full benefits package.

    Skills Alliance are the exclusive partner for this role, please get in contact with Mark Anderson for more details – +44 207 220 6209.

  • Clinical Operations

    £65000 - £90000 per annum, 20% bonus + benefits
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    Great opportunity for an experienced Snr Clinical Project Manager or Clinical Program Manager/AD to join a niche Bitoech working in Oncology. The role is based in Central London with good flexibility.

    The role is with a niche and unique Biotech who are very innovative and work specifically in the Oncology field. The company is growing quickly and have a number of Oncology assets in pre-clinical and early phase trials. This would be working at the cutting edge of research with a great team who are looking to make a real impact on patients’ lives.

    You would be the asset lead for one of their early phase compounds, working on a cross-functional basis and getting involved in a very wide range of activities from protocol writing and development to CRO and vendor selection, working on phase I and II studies. They work in a range of areas in Oncology.

    This is a permanent and full-time role. The role is based in London but there is flexibility to work from home. They offer an excellent salary in the region of £65-90K depending on expeirence + 20% bonus + benefits + possibly options.

    Skills Alliance are the exclusive partner for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click “APPLY NOW”.

  • Clinical Operations

    £60000 - £75000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative vaccine organisation. They are hiring for multiple PMs due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Senior Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous cross-functional project management experience, ideally managing projects from phase I-III. They will consider experienced PMs from Pharma, Biotech or CRO and vaccines experience would be a strong preference. The feedback from recent placements has been outstanding.

    This is a full-time and permanent position to be home-based with infrequent travel to their offices in Central London when normality resumes. They will offer a very competitive salary – circa £60-£75K depending on experience + full benefits package.

    Skills Alliance are the exclusive partner for this role, please get in contact with Mark Anderson for more details – +44 207 220 6209.

  • Clinical Development

    £65000 - £75000 per annum, Excellent package
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    Senior Global Clinical Study Manager position – purely working in Oncology, which could be in solid tumours, haematology or advanced therapies.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a wide-ranging pipeline spanning phase I-III (and late phase) and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Senior Clinical Study Manager / Senior Global Trial Manager role due to growth and new studies coming up, you would be leading their high profile programs in Oncology and they need a an experienced individual, with Oncology trial management and ideally line management experience. They want someone who can work at a senior level and take on a leadership role in the team. It could be or solid tumours, haematology or in their cell & gene therapy team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £65-75K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Development

    £50000 - £65000 per annum, Excellent package
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    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management team. The company are highly innovative and work in a new and exciting area in advanced therapies, they have some exciting partnerships established and are growing rapidly. It is a fanastic time to join and they have a great team in place and is working at the cutting edge of advanced therapies.

    The role will support the PMO to deliver pre-clinical development projects and work closely with the R&D team. They are looking for someone at R&D PM level who has strong Pharma/Biotech experience ideally within pre-clinical – ideally MS Project experience and a PRINCE2 or similar PM qualification would be a plus too. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to go into the Oxford office when normality resumes (with flexibility to WFH 2-3 days). They will offer circa £50-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this R&D Proejct Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Pre-Clinical

    £55000 - £65000 per annum, Excellent package
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    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management / PMO team. The company work in a cutting edge area in the advanced therapies space and have won numerous awards recently for innovation, they are growing rapidly. It is a fantastic time to join and there will be great long-term opportunities.

    The role will support the PM group to deliver a range of interesting projects and it will work closely with Scientific teams. They are looking for someone at R&D PM level who has strong Pharma/Biotech experience ideally in stem cells or gene therapy – ideally experience of Agile methodologies. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to be based in their Cambridge office (with flexibility to WFH 2-3 days). They will offer circa £55-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this Senior Project Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Clinical Development

    £65000 - £78000 per annum, Bonus + benefits + shares
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    Great opportunity for an experienced Study Manager or Senior Study Manager to join a niche Biotech working in advanced therapies. The role is permanent and the office is based in Central London (with flexibility).

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research and we have had great feedback from recent placements.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable and global experience. It is a great opportunity to gain gene therapy/advanced therapies experience.

    This is a permanent and full-time role. The role would be home-based initially with travel to the Central London office. They offer an excellent salary – GBP 65,000-78,000 + bonus + benefits + shares.

    Skills Alliance are the exclusive partner for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    £47000 - £55000 per annum, Bonus + Benefits
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    An Incredible opportunity to join a small Innovative Biotech as a Clinical Study Manager. You will be managing the day to day of studies in GENE Therapy tackling cases in Ophthalmology, Neurology and Rare Diseases.

    Specific Job Duties:

    • Ensure studies are kept within the agreed range and scope to set timelines
    • Oversee study teams throughout the full clinical trial life cycle according to ICH/GCP Guidlines
    • Accountable for site negotistions, ethics and regulatory submissions globally
    • Responsible for external vendors and internal teams.

    Requirements:

    • A Life Sciences Background (Degree is desireable) or Relevant years in the industry
    • Cross-functional/Full-service PM experience
    • Experience in Trial/Project Management in advanced therapies
    • Pharmaceutical/CRO experience (Preffered)

    Based in Central London they are looking for a driven individual with experience executing trials throughout their full life cycle, who can be successful in a growing company through these early phases. on a 9 month FTC Contract. Offering a strong salary £47-55K + Bonus + Benefits.

    Skills Alliance are the preferred supplier for this role. Please contact Matt Askew for more details via matthew.askew@skillsalliance.com or click APPLY NOW.

  • Clinical Operations

    £65 - £75 per annum, Bonus + Benefits
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    An exciting opportunity to join a World Class Pharma Organisation as a Senior Clinical Trial Manager. This organisation is committed to developing innovative treatments and have a diverse pipeline including Oncology.
    Working alongside the Program Manager managing global outsourced studies, working with cross functional departments, vendor management, budget, and timeline management.

    Responsibilities:

    • Management of international outsourced studies.
    • Developing and maintain study budgets and timelines.
    • Drafting and reviewing of clinical study reports and relevant documents.
    • Providing key input on business operation decisions.

    Requirements:

    • Bachelor’s degree – ideally within the life sciences field
    • Oncology experience strong preferred.
    • Ideally international trial management experience.
    • Prior line management desired but not essential


    This is a hybrid role; it is a full time permanent position. They are offering a competitive salary circa £65-75K + bonus + full benefits + stocks

    Skills Alliance are the preferred supplier for the SCTM role. Please contact Shannon Summers for more details on shannon.summers@skillsalliance.com or click APPLY NOW.

  • Clinical Operations

    £47 - £55 per annum, Bonus + Benefits
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    A unique opportunity to join a small and niche Biotech company. This is a full time Clinical Trial Manager role. They are doing cutting edge research within Gene Therapy to overcome complex and untreated diseases. This role would involve the management and coordination of the day-today Gene therapy trials from initiation to close-out.

    Responsibilities:

    • Independently overseeing all clinical operation research activity.
    • Working on global studies from start up to close out.
    • Management of budgets, timelines, and Vendor Management.
    • Working in accordance with ICH/GCP guidelines.
    • Identify and evaluate risks, establish solutions.

    Requirements:

    • Bachelor’s degree – preferably in the life sciences field.
    • Prior experience with Biotech/Pharma or CRO environment.
    • Ideally Clinical Trial Management experience.

    This is a full-time FTC position, based in Central London. This is an office-based role with good flexibility. They would offer a good salary and package circa £47-55K + annual bonus + benefits.

    Skills Alliance are the preferred supplier for the SCTM role. Please contact Shannon Summers for more details on shannon.summers@skillsalliance.com or click APPLY NOW.

  • Clinical Operations

    £70000 - £82500 per annum, Bonus + benefits
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    *PHARMA/CRO EXPERIENCE REQUIRED*

    A great opportunity to join a medium-sized CRO with a great culture and low turnover. They are recruiting for PM and Senior PM roles due to growth and several new business wins. We have had great feedback from recent Snr PM placements.

    This company have a great track record and have been very successful in the past 5 years including throughout COVID. They are a SME CRO who are dynamic and work in very interesting and complex therapy areas. Studies span phases I-IV and they work in Oncology, Rare Disease and Gene Therapy amongst other areas.

    They are recruiting for multiple roles due to new studies coming in and they need an experienced cross-functional/Full-service PM who has international and budget management experience. It could be working on a range of studies and would be working globally. There are also opportunities to progress quickly.

    This is a permanent and full-time role (possibly 0.8 FTE). They have an office in the South East but most of the team are home-based and this can be a remote role across the UK. They will offer a very good salary – GBP 60-82.5K + bonus + benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior Project Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £60000 - £80000 per annum, excellent package
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    A rare opportunity to join a growing Gene Therapies focussed Biotech. This is a permanent Senior Clinical Study Manager role based in Central London.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They are expanding at present and will offer great long-term prospects. The company are looking for a very experienced Senior Clinical Study Manager or Senior Clinical Trial Manager, this would be working on complex and fast-paced studies from phase I-III. They require substantial clinical trial management experience, ideally experience in early phase, complex TAs and international trial management experience. They have multiple programs ongoing and have a global presence.

    This is a full-time and permanent position. It is office-based in the London with flexibility to work from home (home-based during the pandemic). They offer an excellent salary and package around GBP 70-80K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £60000 - £80000 per annum, excellent package
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    A rare opportunity to join a growing early stage Biotech as they build their clinical team. This is a permanent Senior Clinical Study Manager role, mainly home-based with a little travel to the office – Cambs/Herts.

    This exciting and innovative Biotech company are at early stages with trials and just progressing into the clinic. They are expanding at present and will offer great long-term prospects. The company are looking for a very experienced Senior Clinical Study Manager or Senior Clinical Trial Manager, this would be working on complex and fast-paced studies in phase I initially. They require substantial clinical trial management experience, ideally experience in early phase, complex TAs and ideally Biotech experience and/or the ability to work in a fast-paced and ambiguous environment.

    This is a full-time and permanent position. It is mainly home based – going to the office a few days per week. They offer an excellent salary and package around GBP 60-80K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £75000 - £95000 per annum, Excellent package
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    Global Clinical Program Manager position – purely working in Advanced therapies Oncology. Study responsibility and line management of a small team.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a great pipeline spanning phase I-III and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Global Clinical Program Manager role due to growth, you would be leading their high profile programs in advanced therapies Oncology and they need a vastly experienced individual, with Oncology trial management and line management experience. They want someone who can work at a senior level and take on a leadership role in the team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in the London area. They will offer an excellent salary and package – around £75-95K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £80000 - £95000 per annum, Excellent package
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    Share

    Senior Clin Ops role with an Oncology focussed Biopharma in London. Working at program level and leading their leading programs and line managing a small team.

    This is a rare opportunity to join a reputable Biopharmaceutical company with a great reputation, they have a great pipeline spanning phase I-III and trials being run globally. They are growing and will offer excellent long-term opportunities. We have had excellent feedback from recent placements.

    They are recruiting for a Clinical Program Manager / AD role due to growth and new studies coming up, you would be leading their high profile programs in Oncology and they need a vastly experienced individual, with Oncology trial management and line management experience. They want someone who can work at a senior level and take on a leadership role in the team. It could be haematology or solid tumours.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £80-905K basic salary + bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Pre-Clinical

    £55000 - £65000 per annum, Excellent package
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    Share

    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management / PMO team. The company work in a cutting edge area in the advanced therapies space and have won numerous awards recently for innovation, they are growing rapidly. It is a fantastic time to join and there will be great long-term opportunities.

    The role will support the PM group to deliver a range of interesting projects and it will work closely with Scientific teams. They are looking for someone at R&D PM level who has strong Pharma/Biotech experience ideally in stem cells or gene therapy – ideally experience of Agile methodologies. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to be based in their Cambridge office (with flexibility to WFH 2-3 days). They will offer circa £55-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this Senior Project Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Pre-Clinical

    £50000 - £65000 per annum, Excellent package
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    Share

    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management team. The company are highly innovative and work in a new and exciting area in advanced therapies, they have some exciting partnerships established and are growing rapidly. It is a fanastic time to join and they have a great team in place and is working at the cutting edge of advanced therapies.

    The role will support the PMO to deliver pre-clinical development projects and work closely with the R&D team. They are looking for someone at R&D PM level who has strong Pharma/Biotech experience ideally within pre-clinical – ideally MS Project experience and a PRINCE2 or similar PM qualification would be a plus too. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to go into the Oxford office when normality resumes (with flexibility to WFH 2-3 days). They will offer circa £50-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this R&D Proejct Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Clinical Operations

    £65000 - £90000 per annum, 20% bonus + benefits
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    Share

    Great opportunity for an experienced Snr Clinical Project Manager or Clinical Program Manager/AD to join a niche Bitoech working in Oncology. The role is based in Central London with good flexibility.

    The role is with a niche and unique Biotech who are very innovative and work specifically in the Oncology field. The company is growing quickly and have a number of Oncology assets in pre-clinical and early phase trials. This would be working at the cutting edge of research with a great team who are looking to make a real impact on patients’ lives.

    You would be the asset lead for one of their early phase compounds, working on a cross-functional basis and getting involved in a very wide range of activities from protocol writing and development to CRO and vendor selection, working on phase I and II studies. They work in a range of areas in Oncology.

    This is a permanent and full-time role. The role is based in London but there is flexibility to work from home. They offer an excellent salary in the region of £65-90K depending on expeirence + 20% bonus + benefits + possibly options.

    Skills Alliance are the exclusive partner for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click “APPLY NOW”.

  • Clinical Operations

    £65000 - £75000 per annum, Excellent package
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    Share

    Skills Alliance are retained on a unique opportunity with an innovative vaccine organisation. They are hiring for multiple PMs due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Senior Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous cross-functional project management experience, ideally managing projects from phase I-III. They will consider experienced PMs from Pharma, Biotech or CRO and vaccines experience would be a strong preference. The feedback from recent placements has been outstanding.

    This is a full-time and permanent position to be home-based with infrequent travel to their offices in Central London when normality resumes. They will offer a very competitive salary – circa £65-£75K depending on experience + full benefits package.

    Skills Alliance are the exclusive partner for this role, please get in contact with Mark Anderson for more details – +44 207 220 6209.

  • Clinical Operations

    £65000 - £75000 per annum, Excellent package
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    Share

    Skills Alliance are retained on a unique opportunity with an innovative vaccine organisation. They are hiring for multiple PMs due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Senior Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous cross-functional project management experience, ideally managing projects from phase I-III. They will consider experienced PMs from Pharma, Biotech or CRO and vaccines experience would be a strong preference. The feedback from recent placements has been outstanding.

    This is a full-time and permanent position to be home-based with infrequent travel to their offices in Central London when normality resumes. They will offer a very competitive salary – circa £60-£75K depending on experience + full benefits package.

    Skills Alliance are the exclusive partner for this role, please get in contact with Mark Anderson for more details – +44 207 220 6209.

  • Pre-Clinical

    £55000 - £65000 per annum, Excellent package
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    Share

    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management / PMO team. The company work in a cutting edge area in the advanced therapies space and have won numerous awards recently for innovation, they are growing rapidly. It is a fantastic time to join and there will be great long-term opportunities.

    The role will support the PM group to deliver a range of interesting projects and it will work closely with Scientific teams. They are looking for someone at Senior R&D PM level who has strong Pharma/Biotech experience ideally in cell or gene therapy – ideally experience of Agile methodologies. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to be based in their Cambridge office (with flexibility to WFH 2-3 days). They will offer circa £55-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this Senior Project Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Clinical Operations

    £65000 - £75000 per annum, Excellent package
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Skills Alliance are retained on a unique opportunity with an innovative vaccine organisation. They are hiring for multiple PMs due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Senior Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous cross-functional project management experience, ideally managing projects from phase I-III. They will consider experienced PMs from Pharma, Biotech or CRO and vaccines experience would be a strong preference. The feedback from recent placements has been outstanding.

    This is a full-time and permanent position to be home-based with infrequent travel to their offices in Central London when normality resumes. They will offer a very competitive salary – circa £60-£75K depending on experience + full benefits package.

    Skills Alliance are the exclusive partner for this role, please get in contact with Mark Anderson for more details – +44 207 220 6209.

  • Clinical Operations

    £50000 - £65000 per annum, Excellent package
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management team. The company are highly innovative and work in a new and exciting area in advanced therapies, they have some exciting partnerships established and are growing rapidly. It is a fanastic time to join and they have a great team in place and is working at the cutting edge of advanced therapies.

    The role will support the PMO to deliver pre-clinical development projects and work closely with the R&D team. They are looking for someone at R&D PM level who has strong Pharma/Biotech experience ideally within pre-clinical – ideally MS Project experience and a PRINCE2 or similar PM qualification would be a plus too. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to go into the Oxford office when normality resumes (with flexibility to WFH 2-3 days). They will offer circa £50-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this R&D Proejct Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Pre-Clinical

    £65000 - £75000 per annum, Excellent package
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Skills Alliance are retained on a unique opportunity with an innovative vaccine organisation. They are hiring for multiple PMs due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Senior Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous cross-functional project management experience, ideally managing projects from phase I-III. They will consider experienced PMs from Pharma, Biotech or CRO and vaccines experience would be a strong preference. The feedback from recent placements has been outstanding.

    This is a full-time and permanent position to be home-based with infrequent travel to their offices in Central London when normality resumes. They will offer a very competitive salary – circa £65-£75K depending on experience + full benefits package.

    Skills Alliance are the exclusive partner for this role, please get in contact with Mark Anderson for more details – +44 207 220 6209.

  • Clinical Operations

    £65000 - £90000 per annum, 20% bonus + benefits
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    Share

    Great opportunity for an experienced Snr Clinical Project Manager or Clinical Program Manager/AD to join a niche Bitoech working in Oncology. The role is based in Central London with good flexibility.

    The role is with a niche and unique Biotech who are very innovative and work specifically in the Oncology field. The company is growing quickly and have a number of Oncology assets in pre-clinical and early phase trials. This would be working at the cutting edge of research with a great team who are looking to make a real impact on patients’ lives.

    You would be the asset lead for one of their early phase compounds, working on a cross-functional basis and getting involved in a very wide range of activities from protocol writing and development to CRO and vendor selection, working on phase I and II studies. They work in a range of areas in Oncology.

    This is a permanent and full-time role. The role is based in London but there is flexibility to work from home. They offer an excellent salary in the region of £65-90K depending on expeirence + 20% bonus + benefits + possibly options.

    Skills Alliance are the exclusive partner for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click “APPLY NOW”.

  • Clinical Development

    £65000 - £75000 per annum, Excellent package
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    Share

    Senior Global Clinical Study Manager position – purely working in Oncology, which could be in solid tumours, haematology or advanced therapies.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a wide-ranging pipeline spanning phase I-III (and late phase) and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Senior Clinical Study Manager / Senior Global Trial Manager role due to growth and new studies coming up, you would be leading their high profile programs in Oncology and they need a an experienced individual, with Oncology trial management and ideally line management experience. They want someone who can work at a senior level and take on a leadership role in the team. It could be or solid tumours, haematology or in their cell & gene therapy team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £65-75K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £40000 - £50000 per annum, + Bonus + Benefits
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    Share

    An Incredible opportunity to join a growing CRO who focus on Oncology, Neurology and Rare Diseases projects. Working alongside exciting small – medium Biotechs across phases I-III.

    This innovative company have a great opportunity for a CRA II to join and take on a role with minimal on site monitoring, Complex engaging studies and a wide ranging role to build your experience.

    Specific Job Duties:
    • Conduct remote monitoring and occasional on-site visits.
    • Monitor the progress of reports to the local ethics committee and other regulatory
    applications, including online submissions for Global studies
    • Track and review Contracts, Budgets and Timelines for Projects
    • Study feasibility assessments for international sites
    • Liaise with Sponsors, Investigators and Study Teams

    Requirements:
    • Mandatory Life Science background (Degree is desireable) or equivalent years of industry
    and monitoring experience
    • Minimal travelling– approximately 2-3 Visits per month

    It is full-time and permanent Role, which is primarily home-based with minimal travel to sites. They will offer a very good salary – £40-51K + Profit Share + Benefits.

    Skills Alliance are the preferred supplier for this role. Please contact Matt Askew for more details on matthew.askew@skillsalliance.com or click APPLY NOW.

  • Pre-Clinical

    £55000 - £65000 per annum, Excellent package
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management / PMO team. The company work in a cutting edge area in the advanced therapies space and have won numerous awards recently for innovation, they are growing rapidly. It is a fantastic time to join and there will be great long-term opportunities.

    The role will support the PM group to deliver a range of interesting projects and it will work closely with Scientific teams. They are looking for someone at R&D PM level who has strong Pharma/Biotech experience ideally in stem cells or gene therapy – ideally experience of Agile methodologies. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to be based in their Cambridge office (with flexibility to WFH 2-3 days). They will offer circa £55-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this Senior Project Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Clinical Operations

    £70000 - £82500 per annum, Bonus + benefits
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    Share

    *PHARMA/CRO EXPERIENCE REQUIRED*

    A great opportunity to join a medium-sized CRO with a great culture and low turnover. They are recruiting for PM and Senior PM roles due to growth and several new business wins. We have had great feedback from recent Snr PM placements.

    This company have a great track record and have been very successful in the past 5 years including throughout COVID. They are a SME CRO who are dynamic and work in very interesting and complex therapy areas. Studies span phases I-IV and they work in Oncology, Rare Disease and Gene Therapy amongst other areas.

    They are recruiting for multiple roles due to new studies coming in and they need an experienced cross-functional/Full-service PM who has international and budget management experience. It could be working on a range of studies and would be working globally. There are also opportunities to progress quickly.

    This is a permanent and full-time role (possibly 0.8 FTE). They have an office in the South East but most of the team are home-based and this can be a remote role across the UK. They will offer a very good salary – GBP 60-82.5K + bonus + benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior Project Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £75000 - £95000 per annum, Excellent package
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    Share

    Global Clinical Program Manager position – purely working in Advanced therapies Oncology. Study responsibility and line management of a small team.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a great pipeline spanning phase I-III and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Global Clinical Program Manager role due to growth, you would be leading their high profile programs in advanced therapies Oncology and they need a vastly experienced individual, with Oncology trial management and line management experience. They want someone who can work at a senior level and take on a leadership role in the team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in the London area. They will offer an excellent salary and package – around £75-95K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £60000 - £80000 per annum, excellent package
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    Share

    A rare opportunity to join a growing early stage Biotech as they build their clinical team. This is a permanent Senior Clinical Study Manager role, mainly home-based with a little travel to the office – Cambs/Herts.

    This exciting and innovative Biotech company are at early stages with trials and just progressing into the clinic. They are expanding at present and will offer great long-term prospects. The company are looking for a very experienced Senior Clinical Study Manager or Senior Clinical Trial Manager, this would be working on complex and fast-paced studies in phase I initially. They require substantial clinical trial management experience, ideally experience in early phase, complex TAs and ideally Biotech experience and/or the ability to work in a fast-paced and ambiguous environment.

    This is a full-time and permanent position. It is mainly home based – going to the office a few days per week. They offer an excellent salary and package around GBP 60-80K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £60000 - £80000 per annum, excellent package
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    A rare opportunity to join a growing Gene Therapies focussed Biotech. This is a permanent Senior Clinical Study Manager role based in Central London.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They are expanding at present and will offer great long-term prospects. The company are looking for a very experienced Senior Clinical Study Manager or Senior Clinical Trial Manager, this would be working on complex and fast-paced studies from phase I-III. They require substantial clinical trial management experience, ideally experience in early phase, complex TAs and international trial management experience. They have multiple programs ongoing and have a global presence.

    This is a full-time and permanent position. It is office-based in the London with flexibility to work from home (home-based during the pandemic). They offer an excellent salary and package around GBP 70-80K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £70000 - £82500 per annum, Bonus + benefits
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    Share

    *PHARMA/CRO EXPERIENCE REQUIRED*

    A great opportunity to join a medium-sized CRO with a great culture and low turnover. They are recruiting for PM and Senior PM roles due to growth and several new business wins. We have had great feedback from recent Snr PM placements.

    This company have a great track record and have been very successful in the past 5 years including throughout COVID. They are a SME CRO who are dynamic and work in very interesting and complex therapy areas. Studies span phases I-IV and they work in Oncology, Rare Disease and Gene Therapy amongst other areas.

    They are recruiting for multiple roles due to new studies coming in and they need an experienced cross-functional/Full-service PM who has international and budget management experience. It could be working on a range of studies and would be working globally. There are also opportunities to progress quickly.

    This is a permanent and full-time role (possibly 0.8 FTE). They have an office in the South East but most of the team are home-based and this can be a remote role across the UK. They will offer a very good salary – GBP 60-82.5K + bonus + benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior Project Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £65000 - £75000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative vaccine organisation. They are hiring for multiple PMs due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Senior Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous cross-functional project management experience, ideally managing projects from phase I-III. They will consider experienced PMs from Pharma, Biotech or CRO and vaccines experience would be a strong preference. The feedback from recent placements has been outstanding.

    This is a full-time and permanent position to be home-based with infrequent travel to their offices in Central London when normality resumes. They will offer a very competitive salary – circa £60-£75K depending on experience + full benefits package.

    Skills Alliance are the exclusive partner for this role, please get in contact with Mark Anderson for more details – +44 207 220 6209.

  • Pre-Clinical

    £65000 - £75000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative vaccine organisation. They are hiring for multiple PMs due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Senior Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous cross-functional project management experience, ideally managing projects from phase I-III. They will consider experienced PMs from Pharma, Biotech or CRO and vaccines experience would be a strong preference. The feedback from recent placements has been outstanding.

    This is a full-time and permanent position to be home-based with infrequent travel to their offices in Central London when normality resumes. They will offer a very competitive salary – circa £65-£75K depending on experience + full benefits package.

    Skills Alliance are the exclusive partner for this role, please get in contact with Mark Anderson for more details – +44 207 220 6209.

  • Clinical Operations

    £55000 - £65000 per annum, Excellent package
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    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management / PMO team. The company work in a cutting edge area in the advanced therapies space and have won numerous awards recently for innovation, they are growing rapidly. It is a fantastic time to join and there will be great long-term opportunities.

    The role will support the PM group to deliver a range of interesting projects and it will work closely with Scientific teams. They are looking for someone at Senior R&D PM level who has strong Pharma/Biotech experience ideally in cell or gene therapy – ideally experience of Agile methodologies. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to be based in their Cambridge office (with flexibility to WFH 2-3 days). They will offer circa £55-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this Senior Project Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Clinical Development

    £65000 - £75000 per annum, Excellent package
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    Senior Global Clinical Study Manager position – purely working in Oncology, which could be in solid tumours, haematology or advanced therapies.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a wide-ranging pipeline spanning phase I-III (and late phase) and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Senior Clinical Study Manager / Senior Global Trial Manager role due to growth and new studies coming up, you would be leading their high profile programs in Oncology and they need a an experienced individual, with Oncology trial management and ideally line management experience. They want someone who can work at a senior level and take on a leadership role in the team. It could be or solid tumours, haematology or in their cell & gene therapy team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £65-75K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Development

    £65000 - £90000 per annum, 20% bonus + benefits
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    Great opportunity for an experienced Snr Clinical Project Manager or Clinical Program Manager/AD to join a niche Bitoech working in Oncology. The role is based in Central London with good flexibility.

    The role is with a niche and unique Biotech who are very innovative and work specifically in the Oncology field. The company is growing quickly and have a number of Oncology assets in pre-clinical and early phase trials. This would be working at the cutting edge of research with a great team who are looking to make a real impact on patients’ lives.

    You would be the asset lead for one of their early phase compounds, working on a cross-functional basis and getting involved in a very wide range of activities from protocol writing and development to CRO and vendor selection, working on phase I and II studies. They work in a range of areas in Oncology.

    This is a permanent and full-time role. The role is based in London but there is flexibility to work from home. They offer an excellent salary in the region of £65-90K depending on expeirence + 20% bonus + benefits + possibly options.

    Skills Alliance are the exclusive partner for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click “APPLY NOW”.

  • Clinical Operations

    £50000 - £65000 per annum, Excellent package
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    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management team. The company are highly innovative and work in a new and exciting area in advanced therapies, they have some exciting partnerships established and are growing rapidly. It is a fanastic time to join and they have a great team in place and is working at the cutting edge of advanced therapies.

    The role will support the PMO to deliver pre-clinical development projects and work closely with the R&D team. They are looking for someone at R&D PM level who has strong Pharma/Biotech experience ideally within pre-clinical – ideally MS Project experience and a PRINCE2 or similar PM qualification would be a plus too. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to go into the Oxford office when normality resumes (with flexibility to WFH 2-3 days). They will offer circa £50-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this R&D Proejct Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Clinical Development

    £65000 - £75000 per annum, Excellent package
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    Senior Global Clinical Study Manager position – purely working in Oncology, which could be in solid tumours, haematology or advanced therapies.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a wide-ranging pipeline spanning phase I-III (and late phase) and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Senior Clinical Study Manager / Senior Global Trial Manager role due to growth and new studies coming up, you would be leading their high profile programs in Oncology and they need a an experienced individual, with Oncology trial management and ideally line management experience. They want someone who can work at a senior level and take on a leadership role in the team. It could be or solid tumours, haematology or in their cell & gene therapy team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £65-75K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £70000 - £82500 per annum, Bonus + benefits
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    *PHARMA/CRO EXPERIENCE REQUIRED*

    A great opportunity to join a medium-sized CRO with a great culture and low turnover. They are recruiting for PM and Senior PM roles due to growth and several new business wins. We have had great feedback from recent Snr PM placements.

    This company have a great track record and have been very successful in the past 5 years including throughout COVID. They are a SME CRO who are dynamic and work in very interesting and complex therapy areas. Studies span phases I-IV and they work in Oncology, Rare Disease and Gene Therapy amongst other areas.

    They are recruiting for multiple roles due to new studies coming in and they need an experienced cross-functional/Full-service PM who has international and budget management experience. It could be working on a range of studies and would be working globally. There are also opportunities to progress quickly.

    This is a permanent and full-time role (possibly 0.8 FTE). They have an office in the South East but most of the team are home-based and this can be a remote role across the UK. They will offer a very good salary – GBP 60-82.5K + bonus + benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior Project Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £60000 - £80000 per annum, excellent package
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    A rare opportunity to join a growing Gene Therapies focussed Biotech. This is a permanent Senior Clinical Study Manager role based in Central London.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They are expanding at present and will offer great long-term prospects. The company are looking for a very experienced Senior Clinical Study Manager or Senior Clinical Trial Manager, this would be working on complex and fast-paced studies from phase I-III. They require substantial clinical trial management experience, ideally experience in early phase, complex TAs and international trial management experience. They have multiple programs ongoing and have a global presence.

    This is a full-time and permanent position. It is office-based in the London with flexibility to work from home (home-based during the pandemic). They offer an excellent salary and package around GBP 70-80K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £60000 - £80000 per annum, excellent package
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    A rare opportunity to join a growing early stage Biotech as they build their clinical team. This is a permanent Senior Clinical Study Manager role, mainly home-based with a little travel to the office – Cambs/Herts.

    This exciting and innovative Biotech company are at early stages with trials and just progressing into the clinic. They are expanding at present and will offer great long-term prospects. The company are looking for a very experienced Senior Clinical Study Manager or Senior Clinical Trial Manager, this would be working on complex and fast-paced studies in phase I initially. They require substantial clinical trial management experience, ideally experience in early phase, complex TAs and ideally Biotech experience and/or the ability to work in a fast-paced and ambiguous environment.

    This is a full-time and permanent position. It is mainly home based – going to the office a few days per week. They offer an excellent salary and package around GBP 60-80K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £75000 - £95000 per annum, Excellent package
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    Global Clinical Program Manager position – purely working in Advanced therapies Oncology. Study responsibility and line management of a small team.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a great pipeline spanning phase I-III and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Global Clinical Program Manager role due to growth, you would be leading their high profile programs in advanced therapies Oncology and they need a vastly experienced individual, with Oncology trial management and line management experience. They want someone who can work at a senior level and take on a leadership role in the team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in the London area. They will offer an excellent salary and package – around £75-95K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Pre-Clinical

    £55000 - £65000 per annum, Excellent package
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    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management / PMO team. The company work in a cutting edge area in the advanced therapies space and have won numerous awards recently for innovation, they are growing rapidly. It is a fantastic time to join and there will be great long-term opportunities.

    The role will support the PM group to deliver a range of interesting projects and it will work closely with Scientific teams. They are looking for someone at R&D PM level who has strong Pharma/Biotech experience ideally in stem cells or gene therapy – ideally experience of Agile methodologies. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to be based in their Cambridge office (with flexibility to WFH 2-3 days). They will offer circa £55-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this Senior Project Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Clinical Operations

    £80000 - £110000 per annum, bonus + shares + benefits
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    A great opportunity to join a Rare Disease focused Biotech in a Clinical Program Manager or Senior Clinical Program Manager capacity. Office-based in London with flexiblity.

    Skills Alliance are partnered exclusively with a small and growing early phase advanced therapies focused Biotech who work specifically in the rare genetic disease space. They are at the cutting edge of research and working in a very interesting area, harnessing the innate mechanism of gene activation, their platform enables the development of new medicines that restore normal function to patients’ cells. They have a very exciting pipeline and it is a great time to join the organisation.

    They are looking for someone to come in at Clinical Program Manager, ideally from Biotech, who has worked on complex trials in rare genetic disease. The role will involve program management and hands on project work (early phase trials). They need someone who has been the global lead on trials and has program management experience, who can come in and hit the ground running. Experience in advanced therapies would be an advantage and it would be working across phases I-II.

    Responsibilities include the design and execution the operational strategy, including oversight of CROs and vendors. Experience in writing study protocols, study procedure manuals, informed consent forms and clinical study reports, working with investigators, external experts, vendors is also required.

    This is a permanent and full-time position. They are based in Central London so an excellent location, it would be an office-based role with flexibility to work from home. They would offer a great salary and a package in excess of £100K (+ bonus + benefits + potentially share options).

    Skills Alliance are the exclusive partner for this role. Please contact Mark Anderson for more details on 0207 220 6209 or click APPLY NOW.

  • Clinical Development

    £100000 - £130000 per annum, Excellent package
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    Skills Alliance are partnered exclusively on a unique opportunity with an innovative vaccine organisation. They are hiring for a Head of Clinical Development (Science & Strategy) due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Head of Clin Dev Science and Strategy will report to the Global Head of Clin Dev and be a subject-matter expert in clinical vaccine development and science. You will be responsible for building, strengthening, and leading a team of clinical development experts and immunologists (line management responsibility). You will contribute to the development of innovative clinical scientific and strategic concepts and activities related to epidemic outbreaks across the vaccine development cycle (early/late development). They require strong clin dev experience, either a PhD or MD, strong vaccines/infectious disease experience and line management experience. This person will act as a consultant and needs to have gravitas, working directly with C-suite stakeholders, Reg authorities and bodies such as the WHO.

    This is a full-time and permanent position to be based at their offices in Central London or fully home-based anywhere globally. They will offer a very good salary – circa £100-130K + full benefits package (no bonus as they are a non-for-profit).

    Skills Alliance are the exclusive partner for this role, please get in contact with Mark Anderson for more details – +44 207 220 6209.

  • Clinical Operations

    £80000 - £110000 per annum, bonus + shares + benefits
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    A great opportunity to join a Rare Disease focused Biotech in a Clinical Program Manager or Senior Clinical Program Manager capacity. Office-based in London with flexiblity.

    Skills Alliance are partnered exclusively with a small and growing early phase advanced therapies focused Biotech who work specifically in the rare genetic disease space. They are at the cutting edge of research and working in a very interesting area, harnessing the innate mechanism of gene activation, their platform enables the development of new medicines that restore normal function to patients’ cells. They have a very exciting pipeline and it is a great time to join the organisation.

    They are looking for someone to come in at Clinical Program Manager, ideally from Biotech, who has worked on complex trials in rare genetic disease. The role will involve program management and hands on project work (early phase trials). They need someone who has been the global lead on trials and has program management experience, who can come in and hit the ground running. Experience in advanced therapies would be an advantage and it would be working across phases I-II.

    Responsibilities include the design and execution the operational strategy, including oversight of CROs and vendors. Experience in writing study protocols, study procedure manuals, informed consent forms and clinical study reports, working with investigators, external experts, vendors is also required.

    This is a permanent and full-time position. They are based in Central London so an excellent location, it would be an office-based role with flexibility to work from home. They would offer a great salary and a package in excess of £100K (+ bonus + benefits + potentially share options).

    Skills Alliance are the exclusive partner for this role. Please contact Mark Anderson for more details on 0207 220 6209 or click APPLY NOW.

  • Clinical Operations

    £50000 - £70000 per annum, Excellent package
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    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their CMC team. They are a UK based spin out Biotech who are growing rapidly at present. They have a largely immunotherapeutic pipeline of six clinical product candidates in multiple indications, four of which are in co-development with partners and external funding. They are in early phase with their leading programs. We have had great feedback from previous placements.

    This is a CMC Project Manager role, they are looking for a strong PM candidate, ideally with good CMC or viral vectors manufacturing experience. They require around 3-5 years PM experience, viral vector, cell and gene or biologics experience and someone who can work in a fast paced environment. They will offer excellent long-term opportunities.

    This is a permanent and full-time position. They are based in the Berkshire/Oxfordshire area and it would be an office-based role with flexibility to work from home. The salary would be able to offer is around £50-70K + bonus + excellent benefits.

    Skills Alliance are the preferred partner to recruit this CMC Proejct Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Clinical Operations

    £60000 - £70000 per annum, + Bonus + Benefits + Stock
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    This is an incredible opportunity to join a rapidly growing clinical stage Biotech as a Clinical Study Manager.

    With oversight of the day to day studies in infectious diseases, Oncology and Respiratory. They are partnered with some of the worlds largest Pharmaceutical companies and are backed by VCs for a number of assets across Phases I & II.

    Specific Job Duties:

    • Ensure studies are kept within the agreed range and scope to set timelines.
    • Oversee study teams throughout the full clinical trial life cycle according to ICH/GCP Guidlines.
    • Prepare and manage the design, format, and content of clinical trial related documentation in accordance with regulatory, ethics and project requirements.
    • Responsible for management of external vendors and internal stakeholders.
    • Monitor site progress and ensure projects are meeting company standards.

    Requirements:

    • A Life Sciences Background (Degree is desireable) or Relevant years in the industry.
    • Cross-functional/Full-service PM experience.
    • Experience in Trial/Project Management across early phases.
    • Pharmaceutical/CRO experience (Preffered).

    This is a full-time and Permanent position based in Oxford, they are looking for a driven individual with experience managing trials throughout their full life cycle, who can be successful in a fast growing company in early phase development.

    They are looking to offer between £60K-£70K + Bonus + Benefits + Stock.

    Skills Alliance are the preferred supplier for this role. Please contact Matt Askew for more details via matthew.askew@skillsalliance.com or click APPLY NOW.

  • Clinical Operations

    €55000 - €70000 per annum
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    This is an opportunity with a small but fast growing CRO. They are a family-owned company and have a good working environment. They work in interesting and complex areas including transplantation, rare disease, and gene therapy. There are many opportunities to grow and develop professionally within my client’s company, seeing may placements successfully grow into more senior roles after just a few years.

    They are looking for a strong CRA II (1.5 years+) or Senior CRA (3 years+) candidate with a comprehensive understanding of complex clinical trials. They prefer experience within Phases I-III, across a variety of therapy areas, including, but not limited to: rare disease, oncology & gene therapy. The right candidate will have experience with each type of monitoring visit and be completely autonomous in following protocols.

    They are offering fully remote working, expecting the candidate to travel 5-6 times per month on average. The salary levels are flexible and my client would not want to deny a conversation solely on salary. They also offer very generous sign on bonuses! More details upon application.

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    This is an opportunity with a small but fast growing CRO. They are a family-owned company and have a good working environment. They work in interesting and complex areas including transplantation, rare disease, and gene therapy.

    They are looking for a strong CRA II (1.5 years+) or Senior CRA (3 years+) candidate with a comprehensive understanding of complex clinical trials. They prefer experience within Phases I-III, across a variety of therapy areas, including, but not limited to: rare disease, oncology & gene therapy. The right candidate will have experience with each type of monitoring visit and be completely autonomous in following protocols. The right candidate must speak Dutch, as this role will require communication in Dutch. There are fantastic opportunities to grow within the business in the long term, seeing previous placements move up through the business.

    They are offering fully remote working, expecting the candidate to travel 5-6 times per month on average. The salary levels are flexible and my client would not want to deny a conversation solely on salary, but looking to pay €70k-€80k + a car allowance + bonus / benefits.

  • Clinical Operations

    £60000 - £70000 per annum, benefits + bonus
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    I am partnered with a fast-growing niche biotech company. They are involved in the discovery and development of immunotherapeutic products and vaccines for the treatment and prevention of infectious diseases and cancer.
    They are look for a Study Manager to join their team. They are rapidly expanding at the moment so there are excellent growth opportunities, where you would be able to be involved in different areas and develop within the company. They have a great, friendly working environment with an open-door policy.

    Responsibilities:

    • Management and oversight of all aspects of clinical studies.
    • Selection and oversight of CROs, vendors and CRAs.
    • Preparation and coordination of study documentation.

    Requirements:

    • Bachelor’s degree – ideally within the life sciences field
    • Preferably international trial management experience.
    • Study management experience with a pharma, biotech or CRO background.
    • Oncology and Infectious Disease would be a strong advantage.


    This is a full time and permanent role. This is hybrid role (2 days in the office). They are offering a competitive salary between £60-70K + bonus + benefits + stocks.

    Skills Alliance are the preferred supplier for this Study Manager role. Please contact Shannon Summers for more details on shannon.summers@skillsalliance.com or click APPLY NOW.

  • Clinical Operations

    £53000 - £60000 per annum, benefits + bonus
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


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    I have an exciting opportunity to join a small and growing CRO. They work across a wide range of therapeutic areas such as oncology and infectious disease across all phases I – IV. They are looking for a Clinical Project Manager II to join their small and personal team. They have strong reputation and would offer great long-term prospects.

    Responsibilities:

    • Working in multiple and complex clinical trials across all phases.
    • Management of budgets and timelines.
    • Establishing good client working relationships.
    • Motivate and support junior members of the team and project managers.


    Requirements:

    • Bachelor’s degree – preferably within the life sciences field.
    • Ideally Study/Project Manager experience.
    • Ability to work in a dynamic working environment.


    This is a full time and permanent position. This is mainly homebased role with occasionally travel to the offices. They are offering a competitive salary between £53K – £60K + bonus + benefits.

    Skills Alliance are the preferred supplier for this Study Manager role. Please contact Shannon Summers for more details on shannon.summers@skillsalliance.com or click APPLY NOW.