Senior Manager, Clinical Trial Supply Chain

vor 1 Monat

Marburg an der Lahn, Hessen, Deutschland CSL Behring Vollzeit
Job Summary

We are seeking a highly skilled Senior Manager, Clinical Trial Supply Chain to join our team at CSL Behring. As a key member of our Clinical Supply Chain team, you will be responsible for managing the end-to-end supply chain for assigned clinical studies throughout the multi-year study lifecycle.

Key Responsibilities
  1. Develop and implement clinical supply strategies and plans for assigned studies, ensuring compliance with regulatory requirements and company standards.
  2. Lead demand forecasting and inventory management for clinical supplies, leveraging simulation and optimization tools to optimize supply plans and minimize uncertainties.
  3. Establish and monitor global depot networks to distribute drug supplies and ancillary supplies to countries and sites, ensuring timely and compliant importation and supply.
  4. Develop and implement clinical trial supply documents and training to support study execution, including Investigational Medicinal Product (IMP) manuals and product preparation and administration videos.
  5. Utilize Interactive Response Technology (IRT) systems to ensure reliable and efficient clinical supply to depots and sites, co-developing IRT specifications and participating in user acceptance testing.
  6. Ensure compliance with SOPs and regulations for assigned studies, participating in GxP audits and regulatory inspections as needed.
  7. Create and update budgets for complex studies, monitoring study budget and providing reasons for variances.
  8. Identify opportunities for process improvement and innovation projects, leading or participating in cross-functional teams to drive change.
Requirements
  • University degree in life sciences, engineering, logistics, or equivalent experience.
  • Minimum of 7 years' experience in biopharmaceutical R&D or supply chain, including 4 years' experience in clinical trial supplies leading global studies.
About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

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