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Associate Medical Data Review Manager

Fortrea
4-8 years
Not Disclosed
Bangalore, India
1 June 8, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing

Associate Medical Data Review Manager

Location: Bangalore
Employment Type: Full-Time
Application Deadline: June 30, 2026
Job Requisition ID: 262943

Job Overview

The Associate Medical Data Review Manager is a key member of the Global Medical Review Team, responsible for executing Central Medical Review activities within the Central Monitoring strategy. The role involves collaborating across a matrix environment, proactively communicating with stakeholders, and ensuring the effective execution of Central Monitoring and Central Medical Review Plans to meet client expectations.

The incumbent will support study activities from the launch of the Xcellerate® Medical Review (XMR) tool through study completion and reporting. Responsibilities include conducting medical reviews, identifying patient safety concerns, evaluating safety signals, supporting risk assessments, and providing medical review expertise to project teams and clients.


Key Responsibilities

Central Medical Review & Monitoring

  • Collaborate in the development of Central Monitoring proposal text and review costing estimates.

  • Contribute to proposal strategies when Central Medical Review services are included.

  • Support sponsor presentations and bid defense activities.

  • Ensure timely and accurate tracking and status reporting of medical review activities.

  • Apply clinical data analysis to identify and recommend actions regarding patient safety concerns.

  • Identify and evaluate safety signals using individual case assessments, cumulative data reviews, and signal detection methodologies.

  • Support Risk Assessment and Categorization Tool activities related to medical review.

  • Assist in Critical Data and Process Definition as well as EDC design implementation.

Study Configuration & Planning

  • Support the development of medical review requirements and study visualizations.

  • Draft and maintain the Central Medical Review Configuration Plan throughout the study lifecycle.

  • Collaborate with the Central Monitoring Manager and Project Physician to develop and update Central Monitoring/Central Medical Review Plans.

  • Manage configuration of the Xcellerate® Medical Review (XMR) tool.

  • Program study-specific visualizations within XMR and perform User Acceptance Testing (UAT).

Medical Data Review Activities

  • Conduct ongoing Central Medical Reviews under guidance from the Central Medical Review Plan.

  • Review data at patient and site levels and communicate findings effectively.

  • Discuss findings with the Project Physician and ensure issues are appropriately escalated and resolved.

  • Prepare review reports when required.

  • Provide proactive, data-driven recommendations to stakeholders.

  • Serve as a Subject Matter Expert (SME) when applicable based on experience and qualifications.

Compliance & Quality

  • Ensure inspection readiness for medical assessment activities.

  • Support regulatory authority inspections as required.

  • Collaborate with other Central Monitoring functions to maintain consistency and effectiveness.

  • Identify and recommend process improvements.

  • Propose enhancements to systems, tools, and workflows.

Training & Mentorship

  • Train new team members on project-specific processes and procedures.

  • Mentor junior staff and support team development.

Additional Responsibilities

  • Perform other duties as assigned by management.


Line Management Responsibilities (If Applicable)

  • Manage direct reports and ensure training records remain current.

  • Monitor resource utilization and productivity targets.

  • Cascade relevant information from internal and external meetings to team members.

  • Participate in recruitment and onboarding activities.

  • Support operational efficiency and departmental performance.

  • Communicate operational challenges and improvement opportunities to senior leadership.

  • Manage performance reviews and employee development plans.

  • Ensure smooth functioning of the Central Monitoring department.


Required Qualifications

  • Medical Doctor (MD) degree, Allied Medical Degree, or

  • Postgraduate degree in Life Sciences or related discipline.

  • Equivalent relevant experience may be considered in lieu of educational qualifications.


Required Experience

  • Relevant experience in Medical Review, Clinical Research, Pharmacovigilance, Clinical Data Review, Central Monitoring, or related areas.

  • Experience working in cross-functional clinical research environments is preferred.

  • Equivalent relevant experience may be considered in lieu of educational requirements.


Preferred Skills

  • Clinical data review and interpretation.

  • Patient safety assessment and signal detection.

  • Central Monitoring and Risk-Based Monitoring methodologies.

  • Clinical trial data management systems and EDC platforms.

  • Xcellerate® Medical Review (XMR) experience preferred.

  • Strong analytical, communication, and stakeholder management skills.

  • Regulatory inspection readiness and compliance knowledge.

  • Team mentoring and leadership capabilities.