Senior Clinical Trial Supply Manager
A privately held pharma-company is advertising a vacancy for a Clinical Trial Supply Manager, based in their office in Switzerland. The company is active in the life sciences areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools, and investment management, and focuses on innovative treatments, such as in oncology with a focus on solid tumours, as part of their business. This is an exciting opportunity to work with a leading pharmaceutical organization and support their R&D operations to create new, viable treatments. This will be a contract role, running for a year-long assignment.
- Evaluating the feasibility based on protocol outlines and building a proposal for the supply of clinical trials in terms of packaging design, quality and regulatory compliance, and supply chain.
- Managing the Contract Manufacturing Organization (CMO); performing the operational activities from packaging design to on site delivery, return, reconciliation, and destruction.
- Collaborating to the IMP needs estimates and defining a supply strategy with the CMC Project Leader and the Clinical Trial Manager (CTM).
- Setting 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).
- Coordinating the sponsor and Qualified Persons release of IMP in collaboration with both internal and external (CMO) Quality Management, as well as Regulatory Affairs.
- Ensuring study related key CMC documents are accurate and available in the electronic Trial Master File (e-TMF) as per Good Clinical Practices guidelines.
Skills and Requirements:
- 3 to 5 years of 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) 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.
- Fluency in English, proficiency in French is desirable.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Joshua Godden at +44 2038540101 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.