Clinical Supplies Manager (3 month contract)

Clinical Supplies Manager (3 month contract)

Summary

Join a dynamic pharmaceutical team as a Clinical Supplies Manager, where you'll play a pivotal role in overseeing clinical supply operations across global studies. Reporting to the Associate Director, you'll manage CDMO relationships, ensure compliance with GxP standards, and support investigational product logistics from packaging to distribution. This is a hands-on role for a detail-driven professional who thrives in cross-functional environments and understands the intricacies of clinical trial material (CTM) management, regulatory documentation, and financial tracking.

Key Responsibilities

Technical & Operational Oversight

• Manage CDMO activities related to clinical supplies, including review of Master Batch Records (MBR) and Master Packaging Work Orders (MPWO)
• Oversee packaging, labeling, storage, and distribution documentation for investigational products
• Support clinical supply inventory forecasting using IRT / IWRS systems
• Assist in regulatory submissions (INDs, annual reports, amendments) and SOP development
• Review and interpret study protocols, pharmaceutical stability data, and GMP documentation
• Coordinate investigational product returns and reconciliation post-study

Financial & Vendor Management

Compliance & Quality Support

Must Have Qualifications