Clinical Trial Supply Manager
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Hobson Prior currently have an opportunity for a Clinical Trial Supply Manager to join a medium-sized Pharmaceutical company on a permanent basis in Lausanne. This will be an opportunity to manage the delivery of Investigational Medicinal Products, 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, you will 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 Organisation performing the operational activities from packaging design to on site delivery, return, reconciliation and destruction.
- Set-up the packaging, labeling, storage and management of IMP with the internal (data management, CTM….) and external stakeholders (Contract Research Organisation, CMO, Interactive Response Technology (IRT) vendors).
- Co-operate to the IMP needs estimate and define a supply strategy with the CMC Project Leader and the Clinical Trial Manager.
- 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 as per Good Clinical Practices guidelines.
- Project management skills, expertise in outsourcing and supplier's management.
- French and English fluent, excellent communication skills in both languages.
- Previous experience in Clinical Trial Supplies management from phase I to phase III international clinical studies (double-blind, comparator and standard of care sourcing).
- A vast understanding of regulatory and Good Manufacturing Practices requirements for IMP supply.
- A vast understanding and experience in setting up (specification definition) of the main tools related to IMP management (simulation tools, IRT/Interactive Web Response System).
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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