Clinical Supplies Specialist

Job Summary

The Clinical Supply Specialist supports multiple clinical programs by independently coordinating clinical supply activities throughout all phases of clinical studies. This role involves reviewing study protocols, managing packaging and labeling processes, coordinating shipments, monitoring inventory, and supporting supply planning and forecasting. The specialist will collaborate closely with cross-functional teams and external vendors to ensure compliant, timely delivery of clinical trial materials.

Responsibilities

• Plan and execute clinical packaging projects, including CMO scheduling, label production, and packaging.
• Review clinical trial protocols to determine supply needs and study impact.
• Coordinate and track global drug shipments; maintain inventory at depots and clinical sites.
• Perform drug accountability and reconcile depot, site, and sponsor inventories.
• Serve as primary contact for third-party storage, distribution, and packaging vendors.
• Maintain traceable documentation to support GxP compliance.
• Partner with Quality and Regulatory teams to ensure proper labeling and release of supplies.
• Design or review clinical label text to meet product and regulatory requirements.
• Represent clinical supplies at trial team meetings and communicate timelines and plans.
• Utilize software and internal systems to manage project activities effectively.
• Potential to manage selected clinical supply projects.

Qualifications

• BS/BA in a related discipline with 3 years of experience; or MS/MA with 1 year; or equivalent experience.
• Demonstrated experience in clinical supply planning, labeling, packaging, and distribution.
• Strong understanding of GMP/GCP/GLP regulations and clinical labeling/packaging requirements.
• Experience working with CMOs and knowledge of GMP batch record processes preferred.
• Familiarity with IVRS/IWRS systems for clinical studies.