Medical Data Review

Key Responsibilities

• Collaborate in the development of Central Monitoring proposal text and cost reviews , contributing to overall proposal strategy when Central Medical Review is involved.
• Support sponsor presentations and bid defenses .
• Ensure timely and accurate tracking of project status and deliverables.
• Evaluate safety signals through both individual case assessments and cumulative data review.
• Contribute to the Risk Assessment and Categorization Tool (RACT) related to medical review.
• Support the Data Expert with critical data inputs and Electronic Data Capture (EDC) design implementation.
• Draft and maintain the Central Medical Review Configuration Plan throughout the study lifecycle.
• Manage the configuration of the Xcellerate Medical Review tool , including user acceptance testing (UAT) .
• Conduct ongoing Central Medical Review , escalate findings to the Project Physician , and ensure resolution of issues.
• Communicate data-driven decisions clearly and effectively to key stakeholders.
• Ensure inspection readiness for medical review activities and support regulatory inspections when required.
• Collaborate with other Central Monitoring functions to ensure consistency and operational efficiency.
• Provide training on project-specific processes to new team members.

Experience and Qualifications

Skills Required

EDC, Uat, Training