Senior Clinical Trial Supply Manager
CK QLS are recruiting for a Senior Clinical Trial Supply Manager to join a growing biopharmaceutical company at their site based in Lausanne on a on a contract basis for 12 months.
The responsibilities of the Senior Clinical Trial Supply Manager will include:
- Managing the delivery of Investigational Medicinal Products (IMP) including Comparators / Standards of Care according to the study protocol and the project plan
- Evaluating the feasibility and build a proposal for the supply of clinical trials in terms of packaging design, quality and regulatory compliance and supply chain.
- Managing the Contract Manufacturing Organization (CMO) performing the operational activities from packaging design to on site delivery, return, reconciliation and destruction
- Estimating and defining a supply strategy with the CMC Project Leader and the Clinical Trial Manager (CTM)
- Setting 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)
- Previous experience within Clinical Trial Supplies management for phase I to phase III international clinical studies (double-blind, comparator and standard of care sourcing)
- A 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
For more information or to apply for this Senior Clinical Trial Supply Manager , please contact Jocelyn on 0041 (0) 782 516 595 or email firstname.lastname@example.org. Please quote reference QLS 47313 in all correspondence.
Please send all of your correspondence in English.