Clinical Data Manager, Oncology

• 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 contributing effectively as part of a matrixed team environment

• Bachelor's degree in a scientific, health-related, or quantitative discipline required

Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.