Description:
This is a remote position
Job Overview:
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.
KEY RESPONSIBILITIES:
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.
PROFESSIONAL EXPERIENCE/QUALIFICATIONS:
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 contributing effectively as part of a matrixed team environment
Education & Experience Requirements:
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.