Title: Senior Manager, Clinical Supply Chain
Job ID: 36468761
Location: Marlborough, MA
Duration: 09+ months contract (+Possibility of extension)
Details
* 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.
Requirements
* BS/BA degree (Masters preferred) in life sciences or business major or equivalent required.
* Minimum 5-7 years in life sciences industry related experience, including Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trials Coordination.
* At least 3+ years in Clinical Supplies Management.
* Proficient knowledge of Microsoft Excel, PowerPoint, and Project software required.
* APICS certification (CPIM, CLTD, CSCP) preferred.
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