We are looking for a Clinical Trial Supply Manager in order to manage the delivery of Investigational Medicinal Products (IMP) including Comparators / Standards of Care according to the study protocol and the project plan in terms of quantity, quality and timelines.
Join the Pharmaceutical Development Department of one of our prestigious client, based in the canton of Vaud and allowing home-based from anywhere in Europe.
Based on protocol outlines, you 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
You manage the Contract Manufacturing Organization (CMO) performing the operational activities from packaging design to on site delivery, return, reconciliation and destruction
You collaborate to the IMP needs estimate and define a supply strategy with the CMC Project Leader and the Clinical Trial Manager (CTM)
You 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)
You coordinate the sponsor and Qualified Person release of IMP in collaboration with both internal and external (CMO) Quality Management, as well as Regulatory Affairs
You ensure study related key CMC documents are accurate and available in the electronic Trial Master File (e-TMF) as per Good Clinical Practices guidelines
Your Profile :
At least 4year of experience in Clinical Trial Supplies management within the Pharmaceutical industry for phase I to phase III international clinical studies (double-blind, comparator and standard of care sourcing)
A combined experience of clinical trial supplies with both Sponsor and CRO is a plus
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.
First experience of project management skills, with expertise of outsourcing
English fluent, good knowledge of French an asset
For more information, please contact : Morgane CAYUELA: email@example.com
Life Sciences Recruitment Specialist
Team Leader & Recruitment Management Life Sciences