Clinical Data Manager, Oncology

Key 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.

Professional Experience/Qualifications

• 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.