Senior Manager, RTSM Lead, Clinical Supply & External Manufacturing

Senior Manager role leading Randomization and Trial Supply Management (RTSM) systems across global clinical studies at AstraZeneca. Responsible for end-to-end RTSM implementation, vendor management, user acceptance testing, and ensuring compliance with regulatory requirements while maintaining data integrity and patient safety.

Responsibilities

• Lead cross-functional global study teams in RTSM setup, delivery, maintenance, and archival as subject matter expert
• Coordinate vendor partnerships and drive implementation of RTSM standards aligned with regulatory requirements
• Plan and execute user acceptance testing, including test plan authoring and vendor coordination
• Serve as escalation point for RTSM issues and ensure timely resolution through established pathways
• Manage RFP processes, study-level RTSM budgets, and required TMF documentation

Requirements

• 3–5 years of biopharmaceutical industry experience focused on RTSM study support
• End-to-end RTSM systems experience including setup, implementation, closeout, and vendor oversight
• Operational knowledge of blinding controls and data integrity across trial designs
• Strong understanding of RTSM, GCP, GMP, and applicable regulatory requirements
• Demonstrated project management and process improvement skills with excellent planning and analytical abilities
• High proficiency in MS Office (Word, Excel, Outlook, Visio, PowerPoint)

Compensation: $138,392.80–$207,589.20 base annual