Senior Manager, RTSM Lead, Clinical Supply & External Manufacturing

AstraZeneca•Boston, MA

1d•Hybrid

About The Position

The Senior Manager, RTSM Lead will shape the design and operation of IRT/RTSM across global clinical studies. Based in Boston, this role leads cross-functional teams and vendor partnerships to ensure clinical sites receive the right medicine for the right patient at the right time, while protecting patient safety and data integrity and supporting timely study delivery. The role is generally conducted in an office environment, with an average expectation of at least four days per week in the office and flexibility around individual needs. The role oversees end-to-end RTSM setup, delivery, maintenance, and archival; supports vendor oversight and governance; and plans and executes user acceptance testing. It also manages study-level issues, required documentation, RFP processes, and RTSM budgets, while contributing to process improvement and adoption of effective RTSM solutions. The position supports audits and regulatory inspections and upholds blinding controls and applicable GxP and regulatory expectations. The annual base pay range is $138,392.80–$207,589.20 USD (80%–120%). The role is eligible for short-term incentive bonuses and, for salaried roles, equity-based awards. Benefits include qualified retirement programs, paid time off (including vacation, holidays, and leaves), and health, dental, and vision coverage, subject to applicable plan terms.

Requirements

At least 3–5 years of biopharmaceutical industry experience focused on RTSM study support.
End-to-end RTSM systems experience, including setup, implementation, closeout, issue management, and vendor oversight.
Experience with different trial and study designs across therapeutic areas, including operational knowledge of maintaining blinding controls and data integrity.
Strong understanding of RTSM, GCP, GMP, and applicable regulatory requirements.
Demonstrated project management and process improvement skills.
Excellent planning, organizational, and analytical skills.

Nice To Haves

At least 5 years of RTSM experience in the biopharmaceutical industry, including at least 3 years managing complex studies and/or projects.
Bachelor’s degree, MBA, or equivalent level of experience.
Business process mapping experience.
Excellent written and verbal communication and strong interpersonal skills.
High proficiency in Microsoft Office software, including Word, Excel, Outlook, Visio, and PowerPoint.

Responsibilities

Lead global, cross-functional study teams in end-to-end RTSM setup, delivery, maintenance, and archival, ensuring systems meet study needs and timelines.
Coordinate and manage RTSM vendors to meet timelines, standards, and regulatory requirements; implement RTSM standards and best practices and contribute to governance and vendor oversight.
Plan and execute user acceptance testing, including authoring test plans, coordinating vendor support, and preparing study teams.
Act as the study-level escalation point for RTSM issues and ensure timely, effective resolution through established pathways.
Own required documentation as defined in the TMF and team playbook.
Manage RFP processes and study-level RTSM budgets.
Lead or participate in RTSM improvement initiatives and identify, assess, and help onboard effective RTSM solutions.
Support audits and regulatory inspections and uphold blinding controls and data integrity across study operations.