Clinical Data Manager

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan, operating in the U.S. through Sumitomo Pharma America, Inc. The organization focuses on oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS, with a pipeline of early- to late-stage investigational assets.

• 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 oversee CROs and data management vendors, reviewing deliverables, metrics, timelines, and issue escalation.
• Perform and/or oversee database build, edit check specification review, UAT planning and execution, database modifications, and 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 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.

• 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.
• Understanding of oncology clinical trials, endpoints, and data flow preferred.
• 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.
• Oncology experience preferred.
• Equivalent combination of education and experience may be considered.

Base salary range: $ – $.

Benefits include merit‑based salary increases, short‑term incentive plan participation, eligibility for a 401(k) plan, medical, dental, vision, life, and disability insurance, and a comprehensive paid time‑off policy (flexible PTO, 11 paid holidays, additional shutdown period in December, 80 hours of paid sick time upon hire and annually thereafter).

Primarily remote role with periodic on‑site meetings in office. Domestic and international travel as needed.

Fast‑paced environment requiring the ability to exercise appropriate judgment, indicate high initiative and independence, and possess excellent written and oral communication skills. Ability to use a personal computer for extended periods of time.

Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre‑employment drug test.

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 or domestic partnership status, sex, gender, sexual orientation, disability, veteran or military status, domestic violence victim status, atypical cellular or blood trait, genetic information, or any other characteristic protected by law.