Driving global clinical supply strategies that keep groundbreaking oncology and biotech trials on track.
Proclinical is seeking a Clinical Supply Chain Director to oversee and manage clinical supply chain operations for international studies in the oncology and biotechnology sectors. This role involves planning, forecasting, and managing clinical drug supplies, as well as coordinating with vendors and internal teams to ensure seamless execution of clinical study strategies. The position requires expertise in European and global supply chain operations, including compliance with EMA Clinical Trials Regulation No. 536-2014, QP release processes, and cold chain logistics.
Responsibilities:
- Act as the primary clinical supply chain contact for assigned studies.
- Manage clinical drug supply planning, resupply requests, and inventory levels.
- Oversee clinical packaging, labeling (including booklet labels), and distribution.
- Coordinate import/export logistics, customs forms, and auxiliary product procurement.
- Supervise vendors, including shipping/logistics providers, depots, and IRT vendors.
- Ensure compliance with GxP documentation and training requirements.
- Monitor temperature-controlled logistics and handle temperature excursion management.
- Develop and execute global inventory supply plans aligned with study timelines.
- Prepare and manage clinical supply projections and budgets.
- Review and approve packaging, labeling documents, and batch records.
- Maintain clinical supply documentation in the Trial Master File (TMF).
- Support inspection readiness efforts for audits and regulatory inspections.
- Assist in the design, build, and testing of IRT/RTSM systems.
Key Skills and Requirements:
- Bachelor's degree in a relevant field.
- Proven experience in clinical supply management and logistics within the pharmaceutical industry.
- Familiarity with EU and international clinical studies, including EMA regulations.
- Proficiency in GxP standards and pharmaceutical industry procedures.
- Strong organizational skills to manage projects, resources, and budgets in a dynamic environment.
- Expertise in clinical blinding practices and cold chain logistics.
- Proficient in Microsoft Excel and other relevant tools.
If you are having difficulty in applying or if you have any questions, please contact Ed Little at e.little@proclinical.com.
Apply Now:
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