Job Overview:
The Medical Data Review Specialist II- is a senior member of the Global Medical Data Review Team with responsibility for execution of key Central Medical Review activities and assists senior staff and Medical Monitors in the execution of their responsibilities. The Medical Data Review Specialist II -collaborates with the study team to execute central monitoring aspects of clinical trials to implement and comply with the central monitoring / Central Medical review portion of the Central Monitoring plan. He/she is responsible for the preparation and conduct of Central Medical Review tasks across a series of sponsor projects commencing with Xcellerate Medical Review tool, or similar, launch up to and including the study report. He/she conducts review of Central Medical Review under guidance of a Central Medical Review and/or Central Monitoring Plan and communicates findings at the site, patient level. This review is performed with oversight by the Medical Data Review expert, Project Physician who also acts as an escalation point for the Medical Reviewer.





Summary of Responsibilities:
- Performs ongoing Central Medical Review for multiple studies under guidance of a Medical Review Plan or any applicable documents and communicates findings at patient with Team.
- Support team to ensure Critical Data and Process Definition is completed with Data.
- Management and input from project team and supports implementation of critical data focused EDC design.
- Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems.
- Ensures that tracking and status reporting are performed in a timely and accurate manner. ¨
- Applies data to recommend any patient safety concerns.
- Contributes to the Risk Assessment and Categorization Tool for topics related to medical review and considers risks when planning tools configuration.
- Supports the Data Expert with Critical Data and Process Definition and

📌 med data review specialist II (Bengaluru)
🏢 Fortrea
📍 Bengaluru