Clinical Data Manager

Job Listing ID:

4490584

Job Title:

Clinical Data Manager Application Deadline:

Open Until Filled

Job Location:

Salem

Date Posted:

05/12/2026

Hours Worked Per Week:

Not Provided Shift:

Not Provided Duration of Job:

Either Full or Part Time, more than 6 months You may contact this employer directly. (Obtain the contact information to print or add to your jobs.)

Job Summary:

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. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com 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 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. 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 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. Knowledge, Skills, and Abilities 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 c...

Job Classification:

Data Scientists Access our statewide or regional occupation report for more information about wages, employment outlooks, skills, training programs, related occupations, and more. Compensation

Salary:

Not Provided Job Requirements

Experience Required:

 See Job Summary

Education Required:

None

Minimum Age:

N/A Gender:

N/A