Senior Manager, Clinical Supply Chain - Contract

Duties
Responsible for managing drug supply planning, inventory control, and distribution activities including label/pack scheduling, issue resolution, change implementation, vendor oversight, and scope review related to clinical supplies on multiple clinical programs. In addition, working closely with CMC, Regulatory Affairs, Quality Assurance, Clinical Operations, and /or SMPA external partners and CMOs, as needed, building strong working relationships, support study project teams and ensure timely Investigational Product (IP) for clinical trials.

Skills

• Lead and manage end-to-end Clinical Supply Chain activities (planning, packaging and labeling, distribution, returns and destruction) for assigned clinical programs in early and late phases.
• Develop and manage supply forecasts, supply plans, and timelines in collaboration with Clinical and CMC.
• Manage IP inventory levels at the depots and clinical sites; coordinate the inventory from manufacturer to depot or clinical sites.
• Design and/or review label text to meet product requirements and ensure compliance with US and international regulations.
• Ensures effective management of IP based on study timing and in accordance with clinical protocols, cGMP, GCP, ICH, FDA, and other applicable international, federal, and/or local regulations.
• Collaborate closely with Clinical Operations, CMC, Regulatory Affairs, QA, and PDM to ensure advancement of clinical programs; ensure supplies readiness.
• Manage clinical supply and logistics and resolve issues such as shipment delays, temperature excursions, import/export; work closely internal Trade Compliance & Logistics team.
• Demonstrates a solid understanding of clinical study design (randomized, blinded, open label etc.) and execution.
• Manage assign clinical trial contracts, purchase orders including invoices and budget for clinical supply vendor; participate in CSC budget and forecast planning.
• Represent Clinical Supply Chain function at clinical trial meetings; communicate plan and timelines to internal and external customers and partners.
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