IRT Manager

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.). The company focuses on oncology, urology, women’s health, rare diseases, cell & gene therapies, and CNS, aiming to accelerate the delivery of novel therapies to patients.

• Provide portfolio-level oversight of RTSM/IRT deployments to ensure consistency across studies, scalability, and alignment with Data Management and SMPA Clinical Inventory Management System (CIMS) standards.
• Act as primary vendor manager for IRT providers: monitor deliverables and performance, manage issues/CAPAs, and drive continuous improvement.
• Plan, execute, and deliver RTSM/IRT projects, managing timelines, budgets, and scope of changes.
• Lead design, development of User Requirement Specification (URS), UAT, deployment, maintenance, and close-out/deactivation of systems.
• Track operational health by trending the number of program changes, data changes, and help desk tickets across portfolio, escalating proactively with study teams and the vendor.
• Manage full RTSM/IRT lifecycle, including study close-out, deactivation, and archival of system documentation and data.
• Provide guidance on system design alternatives and ensure alignment with global protocols/regulations.
• Ensure robust data flows from IRT/RTSM to other clinical systems; specify interfaces, checks, and drive reconciliation (e.g., IRT IDs, visit alignment, drug allocation events vs. EDC).
• Partner with Data Management analytics platforms to surface KPIs/leading indicators and enable risk-based oversight and portfolio reporting.
• Liaise with clinical operations, clinical supply management, data management, IT, and external vendors.
• Work with the Clinical Project Team to define user role-based training for internal/external users and study-agnostic quick reference materials (Study Manager, Site User/CRA, Supply/Depot, Reports).
• Maintain complete, current, and traceable documentation mapped to SOPs/WIs; support internal/external audits and health authority inspections.
• Serve as the main contact for regulatory inspection activities related to the IRT system.
• Stay updated on IRT/RTSM industry trends and drive process improvements.

• Bachelor’s degree in Life Sciences, Engineering, Data/Information Science, or related discipline.
• 5–8 years in clinical development; 3 years hands‑on IRT/RTSM leadership (URS, hands‑on configuration, UAT, operations) and multi‑country study experience.
• Strong understanding of subject randomization methods, cohort management, and clinical supply strategies; experience translating these into system logic.
• Familiarity with vendor management and industry best practices.
• Working knowledge of ICH E6 (R2/R3), CSV/validation, data privacy, and GxP expectations.
• Demonstrated capability in data integration and reconciliation (IRT ↔ EDC/CTMS/labs/CIMS) and crafting analytics/KPIs for operational oversight.
• Experience with 4G/endpoint (or equivalent IRT) and integrations into common EDCs/CTMS and analytics platforms.
• Oncology experience; adaptive or complex designs (basket/umbrella, dose‑escalation, cohort expansions).
• Systems thinking & data fluency—sees end‑to‑end data flows; anticipates downstream impacts.
• Structured problem solving—converts protocol and supply complexities into clear, testable requirements.
• Strong analytical, communication, and problem‑solving skills.
• Delivery focus—plans, prioritizes, and lands releases with minimal defect escape.

The base salary range for this role is $134,000 to $167,500. Compensation includes merit‑based increases, a short incentive plan, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurance, and paid time off. Total compensation will depend on individual experience, skills, education, and other factors permitted by law.

Disclaimer:
The above statements describe the general nature and level of work performed by people assigned to this classification and are not an exhaustive list of all responsibilities, duties, and skills required. All personnel may be required to perform duties outside of their normal…