• 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
• Ensure study related key CMC documents are accurate and available in the electronic Trial Master File (e-TMF) as per Good Clinical Practices guidelines
• Profound 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
• English fluent, French is desirable but not mandatory
• International company
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