Global RTSM Lead, Clinical Supply & Manufacturing

Alexion Pharmaceuticals, Inc.; Boston (MA); On-site; USD 138,000 - 208,000; Full time

Benefits offered by this job

Short-term incentives

Equity-based awards

Retirement programs

Paid time off

Health, dental and vision coverage

Job summary

Alexion Pharmaceuticals, Inc. in Boston is seeking a Senior Manager, RTSM Lead to design and run IRT/RTSM across global studies. You will lead cross-functional teams, drive UAT readiness, and ensure data integrity while partnering with vendors to deliver on study timelines.

The role focuses on blinding controls, regulatory compliance, and continuous improvement in a fast-paced clinical supply environment. A strong project-management background is essential.

Qualifications

• 3–5 years in biopharma with RTSM experience.
• End-to-end RTSM systems experience including set-up and closeout.
• Experience maintaining blinding controls and data integrity.
• Strong understanding of GCP, GMP and regulatory requirements.
• Demonstrated project management and process improvement skills.
• The role is generally office-based with standard business hours.

Responsibilities

• RTSM Leadership and Delivery: lead cross-functional global teams end-to-end.
• Vendor Partnership: manage RTSM vendor against timelines and standards.
• UAT: plan, coordinate, and execute testing for deployments.
• Issue management: serve as study-level escalation point.
• Documentation and Budget: own TMF docs and RTSM budgets.
• Continuous Improvement: drive RTSM improvements and onboarding.
• Compliance: support audits and inspections, uphold data integrity.

Skills

RTSM leadership

Vendor oversight

UAT planning

GxP compliance

Project management

Data integrity

Education

Bachelor’s degree / MBA

Tools

MS Office

Job description

Alexion Pharmaceuticals, Inc. in Boston is seeking a Senior Manager, RTSM Lead to design and run IRT/RTSM across global studies. You will lead cross-functional teams, drive UAT readiness, and ensure data integrity while partnering with vendors to deliver on study timelines.

The role focuses on blinding controls, regulatory compliance, and continuous improvement in a fast-paced clinical supply environment. A strong project-management background is essential.