Senior Manager, RTSM Lead, Clinical Supply & External Manufacturing
About The Position
The Senior Manager, RTSM Lead, based in Boston, leads the design and operation of IRT/RTSM systems across global clinical studies. The role translates standards into practice and manages vendor partnerships to ensure clinical trials are supplied, blinded, and delivered on time. It safeguards data integrity and patient safety while supporting efficient study timelines, particularly for rare and devastating conditions. The position guides cross-functional teams, strengthens quality through user acceptance testing (UAT) and governance, and helps introduce best-in-class solutions into clinical supply operations. The role also supports audits and regulatory inspections and maintains compliance with GxP and regulatory expectations. The role is generally conducted in an office environment. Employees must be able, with or without accommodation, to use a computer; communicate by phone, video, and electronic messaging; problem solve and engage in complex analysis and dialogue; collaborate; and maintain general availability during standard business hours. The position is based in Boston and averages a minimum of four days per week in the office, with individual flexibility respected.
Requirements
- At least three to five 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, including excellent planning, organizational, and analytical skills.
- Ability to use a computer; communicate by phone, video, and electronic messaging; problem solve; engage in complex thought, analysis, and dialogue; collaborate; and maintain general availability during standard business hours.
Nice To Haves
- Five or more years of RTSM experience in the biopharmaceutical industry, including at least three 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 skills and strong interpersonal skills.
- High proficiency in MS Office software, including Word, Excel, Outlook, Visio, and PowerPoint.
Responsibilities
- Lead cross-functional, global study teams in the end-to-end setup, delivery, maintenance, and archival of RTSM systems, ensuring delivery meets study timelines and needs.
- Coordinate and manage the RTSM vendor to deliver against timelines, standards, and regulatory requirements.
- Drive implementation of RTSM standards and best practices, and contribute to internal governance and vendor oversight.
- Plan and execute UAT, including authoring test plans, coordinating vendor support, and preparing study teams.
- Serve as the study-level escalation point for RTSM issues and ensure timely resolution through established pathways.
- Own required documentation as defined in the TMF and team playbook.
- Manage RFP processes and study-level RTSM budgets.
- Participate in and lead RTSM improvement initiatives; identify, assess, and help onboard best-in-class RTSM solutions.
- Support audits and regulatory inspections and uphold blinding controls and data integrity across study operations.
Benefits
- Eligibility for short-term incentive bonuses and equity-based awards for salaried roles.
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health, dental, and vision coverage in accordance with applicable plan terms.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
