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Clinical Supply Chain Associate Breda • SIRE Life Sciences
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Gevraagd
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37 - 40 uur
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Engels (taal)
Aanbod
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Vast contract
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The Company
Our client is a leading global biotechnology company that focuses on discovering, developing, manufacturing, and delivering innovative human therapeutics. The company's mission is to use advanced science and technology to address serious diseases, including cancer, cardiovascular conditions, and autoimmune disorder
The Role
As a Clinical Supply Chain Associate, you will manage the setup and coordination of clinical supply chains for global clinical trials, ensuring compliance with GMP, GDocP, and GDP standards. The position involves handling data management in ERP systems (SAP), coordinating material requests, resolving artwork issues, and maintaining key files and plans. You will support project managers to ensure the timely and efficient execution of supply chain processes, while adhering to regulatory guidelines throughout the clinical trial lifecycle.
Responsibilities
- Manage and update master data in ERP systems (SAP) to support clinical trial setups.
- Initiate and track requests for clinical label materials.
- Ensure timely availability of finished drug products, Bill of Materials (BOM), Work Breakdown Structure (WBS) elements, and Custom Values.
- Set up and maintain Study Design Tables to align with trial needs.
- Coordinate the creation and approval process for clinical artwork, resolving issues and addressing queries as needed.
- Create and maintain the Product Specification File throughout the clinical trial’s duration.
- Develop and manage depot plans and cross docks to support global study distribution.
- Track and report key performance metrics for the Global Setup Lead team.
- Contribute to monthly workforce planning and resource allocation.
- Bachelor’s degree in logistics, business administration, life sciences, or equivalent experience.
- Relevant experience in biotechnology, pharmaceuticals, or regulated international environments.
- Strong understanding of supply chain principles (e.g., BOM) and project management techniques.
- Proficiency in MS Office (Word, Excel) and experience with ERP systems like SAP.
- Knowledge of clinical supply chain management and regulatory guidelines (e.g., GxP, ICH).
- Excellent communication skills, attention to detail, and the ability to prioritize and escalate issues effectively.
54448
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