Senior Manager, RTSM Lead, Clinical Supply & External Manufacturing

Role Overview Are you ready to lead the systems that keep clinical trials supplied, blinded, and on time? As Senior Manager, RTSM Lead, you will shape how we design and run IRT/RTSM across global studies, translating standards into practice and vendor partnerships into reliable delivery. Based in Boston or New Haven, you will sit at the heart of our clinical supply ecosystem, ensuring every site gets the right medicine for the right patient at the right moment. Your work will safeguard data integrity and patient safety while shortening study timelines for people living with rare and devastating conditions. You will guide cross‑functional teams, elevate quality through robust UAT and governance, and bring best‑in‑class solutions into our operating model. How will you use your expertise to unlock smarter, faster trials that reach under‑served patients sooner? Accountabilities RTSM Leadership and Delivery: Lead cross‑functional, global study teams in the end‑to‑end set‑up, delivery, maintenance, and archival of RTSM as the subject‑matter expert, ensuring systems are delivered to study timelines and needs. Vendor Partnership and Standards: Coordinate and manage the RTSM vendor to deliver against timelines and standards in line with regulatory requirements; drive the implementation of RTSM standards and best practices; contribute to internal governance and vendor oversight. User Acceptance and Quality: Plan and execute UAT, including authoring test plans, coordinating vendor support, and preparing study teams, to ensure right‑first‑time deployments and continuous monitoring. Issue Management and Escalation: Serve as the study‑level point of escalation for RTSM issues and ensure effective and timely resolution through established pathways. Documentation and Budget Stewardship: Own required documentation as defined in the TMF and the team playbook; manage RFP processes and study‑level RTSM budgets to ensure clarity, control, and value. Continuous Improvement and Innovation: Participate in and lead improvement initiatives focused on RTSM; identify, assess, and help onboard best‑in‑class RTSM solutions to strengthen clinical supply operations. Compliance and Inspection Readiness: Support audits and regulatory inspections; uphold blinding controls and data integrity across study operations to meet GxP and regulatory expectations. Essential Skills/Experience Minimum of three to five years of experience in the biopharmaceutical industry with focus on RTSM study support. End‑to‑end RTSM systems experience including set‑up, implementation, and closeout of RTSM systems as well as issue management and vendor oversight. Experience with various trial/study designs across different therapeutic areas and the 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. The duties of this role are generally conducted in an office environment. As is typical of an office‑based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; problem solve; engage in complex and non‑linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. Desirable Skills/Experience 5+ years of RTSM experience within biopharma industry with at least 3 years of managing complex studies and/or projects Bachelor's degree, MBA, or equivalent level of experience Business process mapping experience preferred Excellent written and verbal skills and strong interpersonal skills High level of proficiency in MS Office software including: Word, Excel, Outlook, Visio, and PowerPoint Compensation and Benefits The annual base pay (or hourly rate of compensation) for this position ranges from 138,392.80 – 207,589.20 USD Annual (80% – 120%). Our positions offer eligibility for various incentives—an opportunity to receive short‑term incentive bonuses, equity‑based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental and vision coverage in accordance with the terms of the applicable plans. Working Environment In‑person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of four days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Call to Action Lead the RTSM journey that keeps trials moving and patients protected—submit your application to shape how we deliver tomorrow's medicines today. Equal Employment Opportunity Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. Posting Dates Date Posted : 26-Jun-2026 Closing Date : 09-Jul-2026 #J-18808-Ljbffr JobRx, Inc.