Clinical Supply Specialist (5264)
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Clinical Supply Specialist 5264
Our client is a multinational company based in Lausanne performing Clinical Research in areas such as nutritional’s by prototyping capabilities to accelerate the translation of science into innovation.
To strengthen their Clinical Development Unit Team, they are looking for a Clinical Supply Specialist for a 12 x month contract, based in the Vevey area.
The Clinical Supply Specialist provides the Clinical Supply Operations team with deliverables assigned sponsored and/or collaborative clinical and non-clinical supply and/or Contract Packaging and labelling for study executions.
The ideal candidate should have experience in CMO packaging, logistics tracking, documentation review/approvals to perform the clinical packaging, labelling, distribution, inventory, returns and destruction of all products and materials used in clinical trials.
Main Responsibilities:
- Executing of assigned Clinical Supply Studies and inventory plans
- Tracking production schedules and procurement for clinical trial materials through final receipt at depot or clinical sites.
- Monitoring schedule adherence of production schedules and makes course corrections.
- Obtaining approvals of related technical documents such as clinical label text, clinical packaging master batch records, clinical trial protocols and pharmacy manuals.
- Responsible for maintaining GMP inventory reports throughout the applicable supply chains, generates inventory reports, tracks upcoming expiry triggering resupplies, and leads final drug accountability at study end.
- Monitoring and maintaining IWRS reports from IWRS and other sources to provide weekly drug projection and use visual inventory data
- Recommending packaging design, distribution, and blinding strategy
- Reviewing and recommendations of GMP manufacturing processes
- Maintaining KPI templates and gathering monthly/quarterly data
- Tracking PO balances and invoices through payment completion, responsible to stay on or below department budget
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required
- Bachelor’s degree in science, engineering, or another relevant field such as Chemistry, Biology or Engineering and 5 years relevant work experience/Master’s degree in Chemistry, Biology or Engineering and 3-year Clinical Supply specific work experience.
- Computer software proficiency in spreadsheets, presentations, word processing software with advanced Excel skills
- Experience in a GMP manufacturing facility
- APICS CSCP or CPM certification
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