Clinical Data Manager

Sumitomo Pharma•Marlborough, MA

3h•Remote

About The Position

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. This position reports to the Executive Director, Clinical Data Management, Oncology and is part of the Oncology Data Management function, which supports Sumitomo Pharma America’s 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.

Requirements

Strong working knowledge of clinical data management processes, clinical trial conduct, and regulatory requirements (ICH, GCP).
Experience with EDC systems, eCRF design, edit checks, data validation, and database lock processes.
Ability to analyze data trends, metrics, and operational risks to inform decision‑making.
Strong organizational skills with the ability to manage multiple priorities in a fast‑paced environment.
Effective verbal and written communication skills and ability to collaborate cross‑functionally.
High attention to detail, problem‑solving skills, and sound judgment.
Ability to work independently while contributing effectively as part of a matrixed team environment.
Bachelor’s degree in a scientific, health‑related, or quantitative discipline required.
Minimum 4 years of relevant clinical data management experience in the pharmaceutical or biotech industry, with at least 2 years in a Clinical Data Manager role.
Equivalent combination of education and experience may be considered.

Nice To Haves

Understanding of oncology clinical trials, endpoints, and data flow preferred.
Oncology experience preferred.

Responsibilities

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 teams to implement corrective actions.
Support inspection readiness activities, audits, and regulatory inquiries related to clinical data management.
Ensure adherence to Data Management standards, processes, and best practices.
Perform other data management–related duties as required to support departmental and organizational objectives.