Clinical Trial Supply Manager
Debiopharm Group
Lausanne, Vaud, Switzerland
vor 6 Tg.


Debiopharm Group™ (Debiopharm) is a Swiss-based biopharmaceutical group of four companies active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investments.

Debiopharm International SA searches, evaluates and in-licenses promising drug candidates for development. Towards the end of the development process, the products are licensed out to pharmaceutical companies for world-

wide marketing and sales.

For our Pharmaceutical Development Department based in Lausanne, we are looking for a

Clinical Trial Supply Manager

1 year assignment

In this role the incumbent manages 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.

Main responsibilities :

  • Based on protocol outlines, 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.
  • Manage the Contract Manufacturing Organization (CMO) performing the operational activities from packaging design to on site delivery, return, reconciliation and destruction.

  • Collaborate to the IMP needs estimate and define a supply strategy with the CMC Project Leader and the Clinical Trial Manager (CTM).
  • 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).
  • Coordinate the sponsor and Qualified Person release of IMP in collaboration with both internal and external (CMO) Quality Management, as well as Regulatory Affairs.
  • Insure study related key CMC documents are accurate and available in the electronic Trial Master File (e-TMF) as per Good Clinical Practices guidelines
  • Expertise / competences :

  • 3 to 5 years experience of Clinical Trial Supplies management for phase I to phase III international clinical studies (double-
  • blind, comparator and standard of care sourcing).

  • 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.
  • Project management skills, expertise of outsourcing
  • French / English fluent, excellent communication skills in both languages
  • Bewerben
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