In this role you will 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.

RESPONSABILITIES

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

PROFILE

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).
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

APPLICATION

Thans to apply online

Your contact at Kelly:
Mrs Karine Legerot
Consultant Professional Staffing Life Science
Kelly Scientific Geneva

ABOUT KELLY

Kelly Services® is a global leader in providing staff solutions and active in more than 40 countries.
Together with its subsidiaries, Kelly offers a wide variety of outsourcing and consulting services as well as staff services,
from permanent and management positions to temporary positions.
For over 70 years, we have worked with passion and commitment to connect talents with companies.
With more than 200 employees in over 40 branches and specialist departments,
Kelly Services (Switzerland) AG has been active in Switzerland since 1979.

www.kellyservices.ch

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