As the Clinical Trial Supply Manager, you will define and execute the clinical trial supply strategy for clinical trials which includes effective risk management to ensure supply continuity to patients.
You will be the single point of contact at trial level and be responsible for clinical trial supply deliverables maintaining Quality and Compliance through all activities. You will have operational end to end responsibility for assigned activity. You will lead and manage all project and local network activities and participate in cross-functional teams.
- Develop, maintain and execute optimal clinical supply strategy in terms of (but not limited to): packaging design, timeline feasibility, technical feasibility, efficiency, risk management
- Manage CMOs in charge of a range of activities (from packaging design to on site delivery, return, reconsilitation and destruction)
- Coordinate the Qualified peroson and sponsor release of Investigational Medicinal Products (IMP) in collaboration with Regulatory affairs, external (CMO) and internal Quality Management
- Create and maintain clinical supply demand for assigned study
- Ensure the accuracy, consistency and availabiluty of study related CMC documents in eTMF as per Good Clinical Practive Guidelines
- Generate distribution plans for medicinal products, track shipments from central depot to regional hubs and local depots
- Consolidate, maintain and track the clinical trial budget for overall external costs
- University degree in Life Sciences
- Minimum 5 years of experience in clinical trial supply management Phases I-III in the context of international clinical studies
- Strong knowledge of GMP regulations
- Proven experience in setting up from scratch main tools related to the IMP management
- Strong project Management skills
- Previous outsourcing experience is preferred
- Fluent English, French a plus