Manage the delivery of Investigational Medicinal Products (IMP) including Comparators / Non Investigational Products and Ancillaries according to project plan, study protocol and internal processes in terms of quantity, quality, cost and timelines. You report to the Senior, Clinical Supplies Manager.
- 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, in close cooperation with a cross functional team.
- Collaborate to the IMP needs estimate and define a supply strategy with the CMC Leader and the Clinical Operations team.
- Manage the Contract Manufacturing Organization (CMO) performing the operational activities from request for proposal, contract management (in cooperation with Procurement), packaging design to on site delivery, return, reconciliation and destruction.
- Set-up the packaging, labeling, storage and management of IMP with the internal (Clinical Operations, CMC team, Biometry, Quality) and external stakeholders (Contract Research Organization (CRO), CMO, Interactive Response Technology (IRT) vendors).
- Coordinate the Sponsor and Qualified Person/Quality Unit release of IMP in collaboration with both Quality Management as well as Regulatory Affairs, and any external partner.
- Insure study related key CMC documents are accurate and available in the electronic Trial Master File (e-TMF) as per Good Clinical Practices guidelines.
- BS/MS/Engineer/Pharmacist 5Y+ experience in Clinical Supplies management from phase I to phase III international clinical studies (double-blind, comparator), and phase IV.
- Broad understanding of regulatory and Good Manufacturing Practices requirements for IMP manufacturing and supply.
- Broad understanding and experience in setting up (specification definition) of the main tools related to IMP management (IRT).
- Proven records in managing shipment, importation and exportation.
- Project management skills, expertise in outsourcing and suppliers management.