Clinical Supplies Manager (3 month contract)

Job Description

Job Description

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.

• 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

• Prepare and process project budgets and invoices using ARIBA
• Monitor financial tracking and support FP&A with monthly/quarterly accruals
• Draft RFPs and vendor comparison slides to support CDMO selection
• Evaluate vendor proposals for technical fit, cost efficiency, and delivery timelines

• Collaborate with Regulatory Affairs and Quality Assurance on audits, investigations, and documentation
• Execute Clinical Supply portions of User Acceptance Testing (UAT) for IRT systems
• Maintain SOPs aligned with current clinical supply practices and global GxP standards

• Bachelors degree in Chemistry (Analytical preferred)
• 5-8 years in clinical supply chain or analytical lab settings
• Strong command of Excel, Microsoft Office, and inventory forecasting tools
• Experience with ARIBA, CDMO management, and IRT/IWRS platforms
• Knowledge of GCP, cGMP, and global regulatory frameworks (EU QP a plus)
• Exceptional organizational, analytical, and communication skills