Clinical Trial Supply Chain Manager
Vor 5 Tagen
We are seeking a highly skilled Clinical Trial Supply Chain Manager to join our team at CSL Behring. As a key member of our Global Supply Chain Department, you will be responsible for managing the end-to-end supply chain for assigned clinical studies throughout the multi-year study lifecycle.
Key Responsibilities- Supply Chain Strategy and Planning
- Develop and implement multi-year clinical supply strategies and plans for assigned simple to complex clinical studies.
- Gather and document requirements for clinical supplies, influencing protocol design for clinical supply reliability and efficiency.
- Lead demand forecasting for study(ies), leveraging simulation and optimization tools to optimize clinical supply plans and minimize the effect of inherent uncertainties.
- Supply Chain Operations
- Present IMP related CTS topics in Study Execution Teams, Clinical Development Teams, and Product Development Expert Team/Chemistry, Manufacturing, & Controls Team.
- Determine labelling and clinical kit design based on protocol and countries' needs, implementing pooling concepts in the study.
- Establish and monitor global network of regional and global depots to distribute drug supplies and ancillary supplies to countries and sites in assigned clinical studies.
- Coordinate timely and compliant importation and supply of drug supplies and ancillary supplies into regional and global depots, managing inventory levels and product expiry.
- Supply Chain Documentation and Training
- Develop clinical trial supply documents and training to support study execution for clinical sites and patients (e.g. Investigational Medicinal Product (IMP) Manuals, product preparation and administration videos).
- Train external stakeholders (i.e., clinical monitors, clinical site personnel) and internal global clinical study teams regarding IMP handling.
- Supply Chain Compliance and Quality
- Ensure compliance of all clinical study activities with SOPs and regulations for assigned studies.
- Participate in GxP audits and regulatory inspections as needed, investigating deviations, product technical complaints, and temperature excursions (site and transport) in collaboration with CSQ.
- Develop global and harmonized SOPs to assure ongoing quality, compliance, and efficient conduct of clinical supply activities.
- Supply Chain Budgeting and Financial Management
- Create and update 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.
- Monitor study budget and provide reasons for variances, processing accruals as needed.
- Process Improvement and Innovation
- Identify opportunities and establish business cases for process improvement and innovation projects.
- Independently lead or participate in cross-functional process improvement and innovation projects for the clinical supply chain.
To be successful in this role, you will need:
- 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.
- Strong project management skills paired with good communication skills in cross-functional project teams.
- Fluently speaking in German and English.
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.
We value diversity and inclusionAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. We strive to create an environment where everyone feels valued, respected, and supported.
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