4 days left
- Experience Level
- Experienced (non-manager)
Hobson Prior are seeking a CTSM to join a medium sized biopharmaceutical company on a 12-month contract in Lausanne. This is an exciting opportunity to manage the delivery of Investigational Medicinal Products.
Please note that to be considered for this role you must have the right to work in this location.
- 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.
- Coordinate the sponsor and Qualified Person release of IMP in collaboration with both internal and external (CMO) Quality Management, as well as Regulatory Affairs.
- 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).
- To collaborate to the IMP needs estimate and define a supply strategy with the CMC Project Leader and the Clinical Trial Manager.
- You will ensure study related key CMC documents are accurate and available in the electronic Trial Master File (e-TMF) as per Good Clinical Practices guideline.
- At least 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).
- Project management skills, expertise of outsourcing.
- To have a broad understanding and experience in setting up (specification definition) of the main tools related to IMP management (simulation tools, IRT/Interactive Web Response System….)
- To have a broad understanding of regulatory and Good Manufacturing Practices requirements for IMP supply.
- English fluent, French is desirable.
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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