For a client of ours, we are looking for a Senior Clinical Supplies Coordinator
Job Description
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.
Responsibilities:
- 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.
Requirements
- 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.