Job Title: Medical Data Review Manager
Job ID: 255155
Category: Clinical
Location: Bangalore
Work Environment: Office or home-based; minimal travel required
Role Summary
The Medical Data Review Manager is a key member of the Global Medical Review Team, responsible for executing medical data review activities across sponsor projects. This includes oversight of clinical deliverables, risk management, central medical review tasks, and coordination with study teams and clients. May include line management responsibilities.
Primary Responsibilities
Collaborate on the development of Central Monitoring proposals, costing, and strategy when Central Medical Review is included.
Support sponsor presentations and bid defenses.
Ensure timely and accurate tracking and status reporting of clinical data and deliverables.
Analyze data to identify patient safety concerns and evaluate safety signals from individual cases and cumulative assessments.
Contribute to Risk Assessment and Categorization Tool for medical review-related topics.
Support EDC design implementation and define critical data and process requirements.
Develop medical review requirements, including visualizations and data feed integration.
Draft, finalize, and maintain the Central Medical Review Configuration Plan and Central Monitoring/Central Medical Review Plans.
Manage configuration of Xcellerate® Medical Review (XMR) tool, including study-specific visualizations and user acceptance testing.
Perform ongoing Central Medical Review, discuss findings with Project Physician, ensure issues are resolved, and prepare reports as needed.
Act as a subject matter expert, providing data-driven insights to stakeholders.
Ensure inspection readiness for medical assessment activities and support regulatory authority inspections when required.
Collaborate with other Central Monitoring activities for consistency and effectiveness.
Evaluate and submit process improvement suggestions and proposals for enhanced systems/tools.
Provide project-specific training and mentor new team members.
If assigned, manage line management responsibilities:
Assign tasks, supervise, mentor, and evaluate staff performance.
Address HR needs and support recruitment.
Budget and schedule workforce for task execution.
Manage performance reviews and resolve issues of direct reports.
Minimum Required Qualifications
Medical Doctor, allied medical degree, postgraduate in Life Sciences, or equivalent qualifications.
Relevant experience may be considered in lieu of formal education.
Minimum Required Experience
Medical doctors: 5–7 years in medical practice or equivalent clinical research roles.
Paraprofessionals / Life Science graduates: 7–9 years in clinical research or equivalent experience (e.g., clinical monitoring, data management, medical data review, informatics).
Physical Demands / Work Environment
Standard office or home-based work equipment.
Minimal travel required.
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Auckland |New Zealand :
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Japan | Saitama |Tokyo :
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