Clinical Trial Supply Chain Manager
Vor 3 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.
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