Clinical Trial Supply Manager m/f/d, Basel-StadtThe CTSM provides oversight and/or manages the supply chain of Investigational products from finished Drug product including ancillary devices to returned or destroyed IP kits. This includes the documented evidence of sufficient GCP, GMP, GDP and SCM oversight such as but not limited to Clinical Label design (GCP), Packaging Batch record Review (GMP), Temperature excursion follow-up (GDP) and Inventory control (SCM).
Duration: 1 year
Ready to travel internationally - Europe, US, APAC- 10-20%The CTSM serves as a broker role between study vendors involved in IMP packaging and further management (e.g. Packaging and Labelling CMO), Clinical development, Regulatory Affairs, Development Operations, Technical Operations (Supply Chain, Device Development, Product Development, Analytical, CMC Project Management), Quality Assurance and Qualified Person(QP).
Responsibilities: - Interpreting the clinical study protocol and determining study IMP / NIMP / ancillary needs.
- Participating in Pharmacy Manual development and similar instructions for study participants
- With study vendors support develop instructions for IMP and supplies shipment, including temperature excursion management
- Review relevant sections of the IND and MPD to ensure study vendors content is accurate
- Secure the procurement, manufacture (through the CMC/TechOps function), packaging, labeling and release of the supplies for both the initial clinical campaign and any resupplies that are needed.
- Manage and oversee the distribution logistics for assigned projects throughout the planning, execution, and closeout of Phase I - IV clinical studies to ensure the objectives of the studies are met.
- Manage or oversee the end-to-end Clinical Trial Supplies needs across phase I to phase IV studies,
- Support the Demand Planning from supply to distribution planning across the study programs and quality assurance over study supplies
- Critically review all pre-batch specifications documents and post-batch documents and secure that issues identified are resolved with the CTS vendor to allow release
- Act as the Operational Point of Contact between study sponsor and its Packaging and Labelling CMO
- Critically review forecasts of IMP and other supplies from vendors to ensure that these supplies are adequate to cover the intended studies
- Define Risk Management Strategies to mitigate potential disruptions in the clinical supply
- Can act as an unblinded study sponsor representative for activities related to securing adequate oversight, management and forecast of IMP for clinical studies while securing blinding of other study team members
- Secure forecasting of IMP/AMP ancillary needs based on protocol design.
- Participate in IRT specifications as it relates to CTS distribution strategy and management, and participate in UAT prior to IRT Go Live.
- Ensure critical parameters are considered for every distribution strategy; IRT specifications (e.g. initial or resupply quantities); any QP release, expiry, customs, import/export, brokerage or country-specific requirements.
- Accountable for master label generation done by study vendor
- Secure oversight of relabeling activity at local and depot levels.
- Secure final IMP reconciliation.
- Secure essential documentation on procurement, manufacture (through the CMC/TechOps function), packaging, labeling and release of the supplies is filed in the TMF
- Contribute to the CTS budgeting and forecasting for all clinical studies.
- Offer creative solutions/proposals to optimize the clinical supply chain.
- Attend various cross functional project team meetings as needed.
- Conduct and Lead Operational Supply Meetings as needed.
- Work with Clinical Trial Team (CTT) to ensure that forecasting projections and manufacturing schedules are in line with study progress and ongoing needs.
- Support the study teams and Technical Operations with other CTS issues and projects as needed
Requirements: - Bachelor's degree with at least 15 years of pharmaceutical/Biotech clinical development experience.
- Proven track record with at least 10 years of dedicated Clinical Trials and Supply Chain management managing Phase 1 and Phase 3 supplies.
- Proven track record to effectively collaborate with a global group of interdisciplinary teams and vendors.
- Strong proficiency related to ICH Q10 and ICH E6 is essential.
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