Senior Manager, Clinical Trial Supply Chain
vor 3 Wochen
The Clinical Trial Supply Chain Senior Manager is responsible for overseeing the end-to-end supply chain for assigned clinical studies throughout the multi-year study lifecycle. This role independently leads clinical studies to ensure compliant, on-time supply of study medication and ancillary materials for our patients.
Key Responsibilities:
- Gives input to and oversees the implementation and execution of multi-year clinical supply strategies and plans for assigned simple to complex clinical studies.
- Presents IMP related CTS topics in Study Execution Teams, Clinical Development Teams and Product Development Expert Team/Chemistry, Manufacturing, & Controls Team.
- Establishes and monitors global network of regional and global depots to distribute drug supplies and ancillary supplies to countries and sites in assigned clinical studies.
- Develops clinical trial supply documents and training to support study execution for clinical sites and patients.
- Utilizes Interactive Response Technology (IRT) systems to ensure reliable and efficient clinical supply to depots and sites.
- Ensures compliance of all clinical study activities with SOPs and regulations for assigned studies.
- Creates and updates budgets for complex studies including product and packaging and labeling costs, storage and distribution costs, and comparator and ancillary material costs for assigned clinical studies.
- Ensures study reconciliation, returns, destructions are complete and leads lessons learned sessions.
- Identifies opportunities and establishes business cases for process improvement and innovation projects.
Requirements:
- University degree (BSc, MSc, PhD) 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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