IRT Manager

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

The IRT Manager serves as the business/process owner for Interactive Response Technology systems across SMPA oncology studies. This role leads the gathering of study User Requirements Specification and system configuration, User Acceptance Testing (UAT) and release, vendor governance, change control, and data integration/reconciliation. The manager ensures randomization, treatment assignment, and clinical-supply workflows are compliant, reliable, and analytically usable across the portfolio. The position partners closely with Clinical Operations, Clinical Supply Chain, Biostatistics, Regulatory, Quality, and IT to deliver high quality systems that support complex trial designs and global regulatory requirements.

Job Duties and Responsibilities

• 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 deliverable 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 (based on trending the number of program changes, data changes, and help desk tickets by program and 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 and 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 (as applicable) 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.

Education and Experience

• 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 experience →UAT planning and execution→ operations) and multi-country study experience.

• Strong understanding of subject randomization methods, cohort management, and clinical supply strategies (blinded and open label); 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 in 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. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.