Clinical Supply Chain Manager
A growing biopharmaceutical organization focused on advancing multiple clinical programs is looking for a Clinical Supply Chain Manager. The Clinical Supply Chain Manager oversees end‑to‑end planning and execution of clinical trial material (CTM) supply, ensuring timely packaging, labeling, and global distribution in compliance with GxP requirements. This role leads coordination with Contract Development and Manufacturing Organizations (CDMOs) and partners closely with CMC, Clinical Operations, Quality, and Regulatory teams to support ongoing studies.
A key responsibility includes managing Interactive Response Technology (IRT)-system design, UAT, inventory oversight, and reporting-to ensure accurate supply forecasting, site‑level resupply, and TMF‑ready documentation. The Manager also monitors budgets, vendor performance, and supply risks to support uninterrupted clinical operations.
Responsibilities
Supply & Operations
- Develop study‑level CTM forecasts and integrated supply plans aligned with clinical timelines and enrollment.
- Manage global distribution and logistics, including shipment initiation, import/export needs, expiry monitoring, and depot/site inventory.
- Identify supply risks (e.g., delays, temperature excursions) and implement contingency plans.
- Prepare RFPs, support vendor selection, and oversee CDMO/CRO deliverables, contracts, and invoices.
- Provide technical oversight of IRT systems, including UAT, reporting analysis, and reconciliation activities.
- Support protocol review, stability planning, comparator sourcing, and cross‑functional CTM team leadership.
- Review packaging and labeling records and ensure SOPs remain current.
- Support investigational product accountability, returns, reconciliation, and destruction.
Financial Management
- Track study‑specific supply budgets, costs, and invoices; maintain cost trackers and support accruals.
- Participate in annual budgeting and forecasting activities.
Qualifications
- Bachelor's degree in Pharmacy, Life Sciences, or Supply Chain, with 5-10 years of clinical supply experience in the pharmaceutical industry.
- Strong organizational and communication skills; proficiency in Microsoft Office (especially Excel).
- Knowledge of packaging/labeling processes, pharmaceutical stability, GMP/ GCP, distribution (including cold chain), and batch record review.
- Experience with IRT system setup, UAT, troubleshooting, and report interpretation.
- Ability to manage multiple projects, adapt to change, and work effectively in a cross‑functional environment.
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