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)
Your Background:
- 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 jblackham@ckqls.ch. Please quote reference QLS 47313 in all correspondence.
Please send all of your correspondence in English.
