Clinical Trial Supply Manager
For one of our clients, we are currently looking for a Clinical Trial Supply Manager.
- Clinical Supplies Demand, Packaging and Logistics
- Ensure timely delivery of clinical trial supplies for assigned projects and studies
- Agree on project scope with the Clinical and the CMC teams, perform risk assessment and elaborate contingency
- Advising customers from the clinical development and medical marketing functions with regard to packaging and labelling of study drugs for clinical purpose
- Development of study specific packaging and labelling configuration
- Coordinate the production activities with regards to primary packaging (when appropriate), secondary packaging, labelling, and randomization at the supplier level
- Ensure that the operative clinical trial supply tasks are delegated to the service providers and minimize own involvement on the operational level
- Key contact with the suppliers with regards to packaging for studies and randomization
- Ensure coordination between all functions involved in clinical supply such as Clinical Development, Medical Marketing, Biometrics, Regulatory Affairs, Quality Management, Technical Operations, etc.
- Ensure proper batch allocation and compliant process of packaging and labelling activities
- Set-up the worldwide study distribution to ensure proper distribution to the final consignees (investigational sites)including the availability of import license or notifications (study / country / site specific).
- Work on organizational projects aiming at improving the packaging, labelling, and distribution processes in terms of quality, productivity, and costs
- Participation in the development and maintenance of internal quality rules and documents
- Organize proper hand-over of projects including documentation as filed in the project specific TMF
- Business Processes and Technical Documentation
- Approve the packaging and logistics service agreements with the clinical trial material suppliers and corresponding invoices
- Ensure filing and archiving of the CTS part of the Trial Master File.
- Regular update of the clinical supplies’ tracking and reporting using KPIs & annual reports
Qualifications and Experience:
- University degree or equivalent working experience in life sciences
- At least 2 years of experience in different fields of Clinical Trial Supply Management
- Expert in understanding of all impacts of the relevant international current GMP, GDP, and GCP regulations
- Excellent command of common study management tools
- Team spirit
- Flexible work attitude
- Ability to lead the negotiation with all internal and external partners
- Knowledge in risks, bottlenecks, and potential failure points within the clinical trial supply chain
- Excellent command of English (written and spoken), one additional language, preferably German or French is an asset
- Relevant working/residency permit or Swiss/EU-Citizenship required