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Job Description
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
- Experience:
- Medical doctors with 6–7 years of experience in Medical Data Review.
- Location:
- Based in Bangalore, with availability to work 2 PM to 11 PM IST shift.
- Education:
- Medical degree (MBBS/MD) required.