Beschreibung
Clinical Trial Supply Manager (m/f/d)
Reference: -en
Start: asap
Duration: 12 MM+
Main tasks:
- 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
- Collaborate to the IMP needs estimate and define a supply strategy with the CMC Project Leader and the Clinical Trial Manager (CTM)
- 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)
- 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 (e-TMF) as per Good Clinical Practices guidelines
Main qualifications
- Experience of Clinical Trial Supplies management for phase I to phase III international clinical studies (double-blind, comparator and standard of care sourcing)
- Broad understanding and experience in setting up (specification definition) of the main tools related to IMP management (simulation tools, IRT/Interactive Web Response System,…)
- Broad understanding of regulatory and good manufacturing practices requirements for IMP supply
- Project management skills, expertise of outsourcing
- French/English fluent, excellent communication skills in both languages
Main advantages:
- A very renowned company
- Committed, innovative, friendly... team
- You will work in an international environment
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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My contact person:
Dominic Yves Peter
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