Job Title:Clinical Data Manager – Oncology

Clinical Data Manager – Oncology

The Clinical Data Manager, Oncology will support clinical development programs by ensuring high-quality, compliant, and inspection-ready clinical trial data. This role is responsible for the end-to-end execution and oversight of clinical data management activities across assigned oncology studies.

The position will collaborate closely with Clinical Operations, Biostatistics, Medical Monitoring, Safety, Clinical Systems, and external vendors to ensure data quality, operational efficiency, and successful study execution.

• Execute and manage clinical data management activities for assigned oncology clinical trials in accordance with ICH/GCP guidelines, regulatory requirements, and internal procedures.
• Provide oversight of CROs and clinical data management vendors, including review of deliverables, timelines, performance metrics, and escalation of issues.
• Support database build activities, including edit check specification review, User Acceptance Testing (UAT) planning and execution, database modifications, and database lock activities.
• Perform ongoing data review, cleaning, query management, and quality control activities to ensure data accuracy, consistency, and completeness.
• Develop, review, and maintain key Clinical Data Management documents, including:
  Data Management Plans (DMPs), CRF Completion Guidelines, Data Validation Specifications, Data Transfer Specifications.
• Monitor study data metrics, including enrollment status, eCRF completion, query aging, and data quality indicators.
• Provide regular data management updates and status reports to study teams and functional leadership.
• Collaborate cross-functionally with Clinical Operations, Medical Writing, Medical Monitoring, Biostatistics, and Safety teams to support data reconciliation, analysis readiness, and regulatory submissions.
• Identify operational risks, data trends, and quality issues using study metrics and data insights, and partner with teams to implement corrective actions.
• Support inspection readiness activities, audits, and regulatory inquiries related to clinical data management.
• Ensure compliance with clinical data management standards, processes, and best practices.
• Perform additional data management activities as needed to support clinical development objectives.

• Strong knowledge of clinical data management processes, clinical trial operations, and regulatory requirements, including ICH and GCP guidelines.
• Hands-on experience with EDC systems, eCRF design, edit checks, data validation, and database lock processes.
• Understanding of oncology clinical trials, endpoints, and clinical data workflows preferred.
• Ability to analyze data trends, operational metrics, and risks to support decision-making.
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
• Excellent written and verbal communication skills with the ability to collaborate effectively across functional teams.
• Strong attention to detail, problem-solving abilities, and sound judgment.
• Ability to work independently while contributing effectively within a matrixed team environment.

• Bachelor's degree in a scientific, healthcare, life sciences, or quantitative discipline required.
• Minimum of 4 years of clinical data management experience within the pharmaceutical or biotechnology industry.
• At least 2 years of experience working as a Clinical Data Manager.
• Oncology clinical trial experience preferred.
• Equivalent combination of education, training, and experience may be considered.