IRT Systems Operations Manager

Sumitomo Pharma Co., Ltd. is a prominent global pharmaceutical company based in Japan, committed to meeting patient needs across various therapeutic areas, including oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. With a strong portfolio of marketed products and a promising pipeline of investigational assets, we aim to expedite the discovery, research, and development of innovative therapies for patients worldwide. The IRT Systems Operations Manager plays a crucial role in overseeing and managing Interactive Response Technology (IRT) systems specifically for oncology studies. This key position involves gathering user requirements, system configuration, conducting User Acceptance Testing (UAT), and ensuring compliance with clinical-supply workflows throughout our portfolio. You will collaborate closely with Clinical Operations, Clinical Supply Chain, Biostatistics, Regulatory, Quality, and IT teams to develop high-quality systems that meet the intricacies of trial designs and adhere to global regulatory standards. Key Responsibilities: Oversee RTSM/IRT deployments to ensure consistency across studies, scalability, and alignment with Data Management standards. Act as the primary contact for IRT vendors, monitoring deliverables, resolving issues, and driving ongoing improvements. Plan, execute, and deliver RTSM/IRT projects, managing timelines, budgets, and change scopes. Lead the design and development of User Requirement Specifications (URS), UAT, system deployment, maintenance, and deactivation. Monitor operational health by tracking program changes and help desk tickets, proactively escalating issues as needed. Manage the complete RTSM/IRT lifecycle, including study close-out and archival documentation. Guide the development of system design alternatives while ensuring compliance with global protocols and regulations. Facilitate robust data flows between IRT/RTSM and other clinical systems, including reconciliation efforts. Collaborate with Data Management to develop key performance indicators (KPIs) and enable comprehensive portfolio reporting. Communicate effectively with clinical operations, clinical supply management, data management, IT, and external vendors. Define user role-based training for internal and external users, providing study-specific reference materials. Maintain thorough documentation aligned with Standard Operating Procedures (SOPs) and Work Instructions (WIs), supporting audits and inspections. Serve as the primary contact during regulatory inspections related to the IRT system. Stay updated on IRT/RTSM industry trends and actively seek process enhancements. Qualifications: Bachelor's degree in Life Sciences, Engineering, Data/Information Science, or a related field. 5-8 years of experience in clinical development, with a minimum of 3 years in IRT/RTSM leadership. Strong understanding of randomization methods and clinical supply strategies. Familiarity with vendor management principles and industry best practices. Working knowledge of ICH E6 (R2/R3), CSV/validation, data privacy, and GxP expectations. Experience with data integration and reconciliation across clinical systems. Oncology experience with adaptive or complex trial designs preferred. Proficient in viewing end-to-end data flows and anticipating impacts. Excellent analytical, communication, and problem-solving skills. Strong focus on deliverables, with meticulous planning and prioritization. The base salary range for this position is $134,000 to $167,500, which includes merit-based salary increases, participation in a short incentive plan, and eligibility for benefits such as medical, dental, vision, and more. Our flexible time-off policy encompasses paid time off, holidays, and sick leave to ensure a balanced work-life experience. At Sumitomo Pharma America, we embrace diversity and encourage all applicants to apply. All information encountered in this role is confidential, and compliance with regulatory and ethical standards is of utmost importance in our operations. Join us in our mission to create valuable healthcare solutions for people around the globe!

Created: 2026-03-04