Senior Clinical Trial Supply Manager

Senior Clinical Trial Supply Manager

My client is an innovating, dynamic and niche international biopharma company currently expanding their clinical development team.
Due to this growth my client is looking for a Senior Clinical Trial Supply Manager with a strong understanding of clinical studies to join them in Lausanne area.

YOUR RESPONSIBILITIES:

– Anticipate and provide a proposal for the supply of clinical trials for all aspects (packaging design, quality, supply chain,…). Ensure the CMO performing the overall operational activities

– Anticipate the IMP needs estimate and define a supply strategy with the CMC Project Leader and the CTM.

– Manage the packaging, labelling, storage and management of IMP with the internal and external partner

– Lead the sponsor and Qualified Person release of IMP in collaboration with different department and external partners

– Insure study related key CMC documents are accurate and available in the electronic Trial Master File

YOUR PROFILE:

– Minimum 3 years experience of Clinical Trial Supplies management for phase I to phase II international clinical studies, phase III is desirable

– Broad understanding and experience in setting up (specification definition) of the main tools related to IMP management (simulation tools, IRT/Interactive Web Response System,….)

– Good knowledge of regulatory and GMP requirements for IMP supply.

– Project management skills, expertise of outsourcing

– English fluent, French is desirable

For more details, please contact Marine Dollat at mdollat@axepta.com

Marine Dollat mdollat@axepta.com