Global RTSM Lead: Trials Delivery & Data Integrity

Alexion Pharma Spain S.L.; Boston (MA); On-site; USD 138,000 - 208,000; Full time

Benefits offered by this job

Short-term incentive bonuses

Equity-based awards

Retirement programs

Health/dental/vision coverage

Paid time off

Job summary

AstraZeneca in Boston is seeking a Senior Manager, RTSM Lead to oversee RTSM across global studies, ensuring data integrity and on-time delivery of trials. You will guide cross-functional teams, drive governance, and partner with vendors to translate standards into reliable RTSM operations.

The role emphasizes end-to-end RTSM expertise, blinding controls, regulatory compliance, and budget stewardship in a fast-paced biopharma environment.

Qualifications

• Minimum of three to five years in biopharmaceutical RTSM support.
• End-to-end RTSM systems experience including set-up, implementation, and closeout.
• Experience across trial designs and maintaining blinding controls.
• Strong understanding of RTSM, GCP, GMP and regulatory requirements.
• Demonstrated project management and process improvement skills.

Responsibilities

• Lead cross-functional global teams for RTSM setup, delivery, maintenance, and archival.
• Coordinate RTSM vendor to meet timelines and regulatory standards.
• Plan and execute UAT, write test plans, and coordinate vendor support.
• Serve as study-level escalation for RTSM issues and resolution pathways.
• Own TMF documentation and RTSM budgets to ensure clarity and value.
• Lead continuous improvement initiatives and onboard new RTSM solutions.
• Support audits and inspections; uphold blinding controls and data integrity.

Skills

RTSM experience

GxP/GMP knowledge

Project management

MS Office proficiency

Analytical skills

Planning & organizational skills

Education

Bachelor's degree

MBA

Tools

MS Office

Visio

Job description

AstraZeneca in Boston is seeking a Senior Manager, RTSM Lead to oversee RTSM across global studies, ensuring data integrity and on-time delivery of trials. You will guide cross-functional teams, drive governance, and partner with vendors to translate standards into reliable RTSM operations.

The role emphasizes end-to-end RTSM expertise, blinding controls, regulatory compliance, and budget stewardship in a fast-paced biopharma environment.