IRT Systems Manager

Sumitomo Pharma Co., Ltd. is a leading global pharmaceutical company based in Japan, dedicated to addressing patient needs across various therapeutic areas, including oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. With a robust 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 Manager is responsible for the oversight and management of Interactive Response Technology (IRT) systems on oncology studies. This pivotal role involves gathering user requirements, system configuration, conducting User Acceptance Testing (UAT), and ensuring compliance with clinical-supply workflows across the portfolio. The manager collaborates closely with Clinical Operations, Clinical Supply Chain, Biostatistics, Regulatory, Quality, and IT to develop high-quality systems that adhere to complex trial designs and global regulatory standards.

Key Responsibilities :

• Provide oversight of RTSM / IRT deployments, ensuring consistency across studies, scalability, and alignment with Data Management standards.
• Serve as the primary contact for IRT vendors : monitor deliverables, manage issues, and drive ongoing improvements.
• Plan, execute, and deliver RTSM / IRT projects, overseeing timelines, budgets, and change scopes.
• Lead design and development of User Requirement Specification (URS), UAT, system deployment, maintenance, and deactivation.
• Track operational health by monitoring program changes and help desk tickets, and escalate issues proactively.
• Manage the full RTSM / IRT lifecycle, including study close-out and archival documentation.
• Guide system design alternatives while ensuring compliance with global protocols and regulations.
• Ensure robust data flows between IRT / RTSM and other clinical systems, including reconciliation efforts.
• Collaborate with Data Management to develop KPIs and enable portfolio reporting.
• Liaise effectively with clinical operations, clinical supply management, data management, IT, and external vendors.
• Define user role-based training for internal / external users and provide study-specific reference materials.
• Maintain comprehensive documentation aligned with SOPs / WIs and support audits and inspections.
• Act as the primary contact during regulatory inspections related to the IRT system.
• Stay informed on IRT / RTSM industry trends and drive process enhancements.

Qualifications :

The base salary range for this position is $134,000 to $167,500, inclusive of merit-based salary increases, short incentive plan participation, and eligibility for benefits such as medical, dental, vision, and more. Our flexible time-off policy includes paid time off, holidays, and sick leave, ensuring 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. Compliance with regulatory and ethical standards is paramount in our operations.

Join us in our mission to create valuable healthcare solutions for people around the globe!