[Remote] Clinical Data Manager
Note: The job is a remote job and is open to candidates in USA. Sumitomo Pharma America, Inc. is a global pharmaceutical company focused on addressing patient needs in various health domains. The Clinical Data Manager will oversee clinical data management activities for oncology studies, ensuring high-quality and compliant clinical trial data in collaboration with cross-functional teams.
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
Skills
- 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
- 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
- Understanding of oncology clinical trials, endpoints, and data flow preferred
- Oncology experience preferred
Benefits
- Merit-based salary increases
- Short incentive plan participation
- Eligibility for our 401(k) plan
- Medical, dental, vision, life and disability insurances
- Leaves provided in line with your work state
- Flexible paid time off
- 11 paid holidays plus additional time off for a shut-down period during the last week of December
- 80 hours of paid sick time upon hire and each year thereafter
Company Overview
Company H1B Sponsorship