Clinical Data Manager

at Sumitomo Pharma in Boise, Idaho, United States

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, womens 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 or follow us on LinkedIn.

This position reports to the Executive Director, Clinical Data Management, Oncology and is part of the Oncology Data Management function, which supports Sumitomo Pharma Americas clinical development programs by ensuring high-quality, compliant, and inspection-ready clinical trial data. The role is responsible for the end-to-end execution and oversight of clinical data management activities across assigned oncology studies and works closely with Clinical Operations, Biostatistics, Medical Monitoring, Safety, Clinical Systems, and external vendors.

Essential Functions Required for the Job

+ Execute and manage all in house clinical data management activities for assigned oncology trials in accordance with ICH / GCP , regulatory requirements, and internal SOPs.

+ Support and contribute to the oversight of CROs and data management vendors, including review of deliverables, metrics, timelines, and issue escalation.

+ Perform and/or oversee database build, edit check specification review, UAT planning and execution, database modifications, and database lock activities.

+ Conduct ongoing data review, cleaning, query management, and quality control to ensure data accuracy, consistency, and completeness.

+ Develop, review, and maintain Data Management deliverables, including:

+ Data Management Plans (DMPs)

+ CRF Completion Guidelines

+ Data Validation Specifications

+ Data Transfer Specifications

+ Monitor study status metrics (e.g., enrollment, eCRF completion, query aging) and provide regular data management status updates to study teams and functional leadership.

+ Collaborate cross functionally with Clinical Operations, Medical Writing, Medical Monitoring, Biostatistics, and Safety to support data reconciliation, analysis readiness, and submission activities.

+ Identify operational risks, trends, and data quality issues using metrics, audits, and study insights, and partner with team