Senior Clinical Trial Supply Manager

  • Vaud
  • Posted: Nov 16, 2021

We are looking for a Clinical Trial Supply Manager in order to manage the delivery of Investigational Medicinal Products (IMP) including Comparators / Standards of Care according to the study protocol and the project plan in terms of quantity, quality and timelines. Join the Pharmaceutical Development Department of one of our prestigious client, based in the canton of Vaud and allowing home-based from anywhere in Europe.

Responsabilities :

  • Based on protocol outlines, you evaluate the feasibility and build a proposal for the supply of clinical trials in terms of packaging design, quality and regulatory compliance and supply chain
  • You manage the Contract Manufacturing Organization (CMO) performing the operational activities from packaging design to on site delivery, return, reconciliation and destruction
  • You collaborate to the IMP needs estimate and define a supply strategy with the CMC Project Leader and the Clinical Trial Manager (CTM)
  • You set-up the packaging, labelling, storage and management of IMP with the internal (data management, CTM,...) and external stakeholders (Contract Research Organization(CRO), CMO, Interactive Response Technology (IRT) vendors)
  • You coordinate the sponsor and Qualified Person release of IMP in collaboration with both internal and external (CMO) Quality Management, as well as Regulatory Affairs
  • You ensure study related key CMC documents are accurate and available in the electronic Trial Master File (e-TMF) as per Good Clinical Practices guidelines

Your Profile :

  • At least 4year of experience in Clinical Trial Supplies management within the Pharmaceutical industry for phase I to phase III international clinical studies (double-blind, comparator and standard of care sourcing)
  • A combined experience of clinical trial supplies with both Sponsor and CRO is a plus
  • Broad understanding and experience in setting up (specification definition) of the main tools related to IMP management (simulation tools, IRT/Interactive Web Response System,…)
  • Broad understanding of regulatory and Good Manufacturing Practices requirements for IMP supply.
  • First experience of project management skills, with expertise of outsourcing
  • English fluent, good knowledge of French an asset

For more information, please contact : Morgane CAYUELA: mc@axepta.com

Morgane CAYUELA

Morgane CAYUELA

Life Sciences Recruitment Specialist

Noémie OLIVA

Noémie OLIVA

Team Leader & Recruitment Management Life Sciences

Marine DOLLAT

Marine DOLLAT

Life Sciences Recruitment Specialist

Senior Clinical Trial Supply Manager

Nov 16, 2021Senior Clinical Trial Supply ManagerVaud Permanent Job mc@axepta.com Life Sciences

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