What are the responsibilities and job description for the Clinical Supply Chain Manager position at Advanced Clinical?
Location: Remote
Start Date: October 1, 2025
End Date: July 31, 2026
Duration: 10 months
Schedule: Full-time, 40 hours/week
Position 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.
Key Responsibilities
Start Date: October 1, 2025
End Date: July 31, 2026
Duration: 10 months
Schedule: Full-time, 40 hours/week
Position 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.
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.
- 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.
