Senior RTSM Lead — Global Clinical Supply & Manufacturing

AstraZeneca plc; Boston (MA); On-site; USD 138,000 - 208,000; Full time

Benefits offered by this job

Incentives (short-term)

Equity-based awards for salaried roles

Retirement programs

Paid time off

Health, dental, and vision coverage

Job summary

AstraZeneca plc in Boston is seeking a Senior Manager, RTSM Lead to shape IRT/RTSM design and vendor partnerships across global studies. You will lead cross-functional teams to ensure on‑time, right‑first‑time RTSM delivery with strong governance and data integrity.

You will oversee UAT, budgeting, and documentation while ensuring regulatory compliance and blinding controls. This office-based role emphasizes collaboration, problem-solving, and continuous improvement to accelerate trial timelines.

Qualifications

• Minimum of three to five years of RTSM experience in biopharmaceutical industry.
• End-to-end RTSM systems setup, implementation, and closeout.
• Experience across trial designs and maintaining blinding/data integrity.
• Strong understanding of RTSM, GCP, GMP and regulatory requirements.
• Demonstrated project management and process improvement skills.
• Office-based role requires computer use, communication, and collaboration during standard business hours.

Responsibilities

• RTSM Leadership and Delivery: Lead cross-functional, global study teams in RTSM setup, delivery, maintenance and archival.
• Vendor Partnership and Standards: Manage RTSM vendor to meet timelines and regulatory standards; drive RTSM governance.
• User Acceptance and Quality: Plan and execute UAT, coordinate vendor support, ensure right-first-time deployments.
• Issue Management and Escalation: Escalate RTSM issues and drive timely resolution.
• Documentation and Budget Stewardship: Manage TMF documentation and RTSM budgets; oversee RFP processes.
• Continuous Improvement and Innovation: Lead RTSM improvement initiatives and onboard best-in-class solutions.
• Compliance and Inspection Readiness: Support audits and maintain blinding controls and data integrity.

Skills

RTSM experience

Project management

Process improvement

Data integrity awareness

Cross-functional collaboration

Education

Bachelor’s degree/MBA

Tools

MS Office Suite

Job description

AstraZeneca plc in Boston is seeking a Senior Manager, RTSM Lead to shape IRT/RTSM design and vendor partnerships across global studies. You will lead cross-functional teams to ensure on‑time, right‑first‑time RTSM delivery with strong governance and data integrity.

You will oversee UAT, budgeting, and documentation while ensuring regulatory compliance and blinding controls. This office-based role emphasizes collaboration, problem-solving, and continuous improvement to accelerate trial timelines.