Advanced Clinical
Overview
We are seeking an experienced Clinical Supply Chain Manager to oversee end-to-end drug supply planning, inventory management, packaging/labeling, and distribution for multiple clinical programs. This role will partner closely with CMC, Regulatory Affairs, Quality Assurance, Clinical Operations, external vendors, and CMOs to ensure the timely availability of Investigational Product (IP) to support ongoing and upcoming clinical trials. Location and Term
Location: Remote Start Date: October 1, 2025 End Date: July 31, 2026 Duration: 10 months Schedule: Full-time, 40 hours/week Key Responsibilities
Lead and manage all aspects of Clinical Supply Chain for assigned clinical programs (planning, packaging/labeling, distribution, returns, and destruction). Develop and maintain supply forecasts, supply plans, and timelines in collaboration with Clinical and CMC functions. Manage IP inventory levels at depots and clinical sites; oversee transfers from manufacturer to depot or site. Design and/or review label text to meet product requirements and ensure compliance with U.S. and international regulations. Ensure effective management of IP according to study protocols, cGMP, GCP, ICH, FDA, and other applicable regulations. Collaborate with Clinical Operations, Regulatory Affairs, QA, and PDM to ensure program readiness and seamless clinical trial execution. Troubleshoot and resolve supply/logistics issues (e.g., shipment delays, temperature excursions, import/export challenges) in partnership with internal Trade Compliance & Logistics. Demonstrate strong understanding of clinical study design (randomized, blinded, open-label, etc.) and operational requirements. Manage clinical trial vendor contracts, purchase orders, invoices, and budgets; contribute to CSC budget and forecast planning. Represent Clinical Supply Chain in clinical trial meetings, communicating supply plans and timelines to internal and external stakeholders. Qualifications
BS/BA in Life Sciences, Business, or related discipline required; Master’s degree preferred. 5-7 years of experience in the life sciences industry, including roles in Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trials Coordination. Minimum 3 years of direct experience in Clinical Supply Management. Strong knowledge of cGMP, GCP, ICH, FDA, and international regulatory requirements. Proficiency with Microsoft Excel, PowerPoint, and Project software. APICS certification (CPIM, CLTD, or CSCP) preferred. Excellent organizational, problem-solving, and cross-functional collaboration skills.
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We are seeking an experienced Clinical Supply Chain Manager to oversee end-to-end drug supply planning, inventory management, packaging/labeling, and distribution for multiple clinical programs. This role will partner closely with CMC, Regulatory Affairs, Quality Assurance, Clinical Operations, external vendors, and CMOs to ensure the timely availability of Investigational Product (IP) to support ongoing and upcoming clinical trials. Location and Term
Location: Remote Start Date: October 1, 2025 End Date: July 31, 2026 Duration: 10 months Schedule: Full-time, 40 hours/week Key Responsibilities
Lead and manage all aspects of Clinical Supply Chain for assigned clinical programs (planning, packaging/labeling, distribution, returns, and destruction). Develop and maintain supply forecasts, supply plans, and timelines in collaboration with Clinical and CMC functions. Manage IP inventory levels at depots and clinical sites; oversee transfers from manufacturer to depot or site. Design and/or review label text to meet product requirements and ensure compliance with U.S. and international regulations. Ensure effective management of IP according to study protocols, cGMP, GCP, ICH, FDA, and other applicable regulations. Collaborate with Clinical Operations, Regulatory Affairs, QA, and PDM to ensure program readiness and seamless clinical trial execution. Troubleshoot and resolve supply/logistics issues (e.g., shipment delays, temperature excursions, import/export challenges) in partnership with internal Trade Compliance & Logistics. Demonstrate strong understanding of clinical study design (randomized, blinded, open-label, etc.) and operational requirements. Manage clinical trial vendor contracts, purchase orders, invoices, and budgets; contribute to CSC budget and forecast planning. Represent Clinical Supply Chain in clinical trial meetings, communicating supply plans and timelines to internal and external stakeholders. Qualifications
BS/BA in Life Sciences, Business, or related discipline required; Master’s degree preferred. 5-7 years of experience in the life sciences industry, including roles in Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trials Coordination. Minimum 3 years of direct experience in Clinical Supply Management. Strong knowledge of cGMP, GCP, ICH, FDA, and international regulatory requirements. Proficiency with Microsoft Excel, PowerPoint, and Project software. APICS certification (CPIM, CLTD, or CSCP) preferred. Excellent organizational, problem-solving, and cross-functional collaboration skills.
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