My client is an innovating, dynamic and niche growing international pharmaceutical company specialised in Oncology and Infectious Diseases.
My client is looking for a Senior Clinical Trial Supply Manager to work from home anywhere in Europe for a 12-month contract to manage 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.
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 guideline
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
Broad understanding of regulatory and Good Manufacturing Practices requirements for IMP supply.
Project management skills, expertise of outsourcing