Clinical Data Review Specialist II

3 weeks ago


Bengaluru, Karnataka, India MUM Fortrea Development India Pvt Ltd Full time

Job Summary: We are seeking a skilled Medical Data Review Specialist II to join our Global Medical Data Review Team. The successful candidate will be responsible for the execution of key Central Medical Review activities and will assist senior staff and Medical Monitors in the execution of their responsibilities.

Key Responsibilities:

  1. Collaborate with the study team to execute central monitoring aspects of clinical trials and implement the Central Medical Review portion of the Central Monitoring plan.
  2. Prepare and conduct Central Medical Review tasks across a series of sponsor projects using Xcellerate Medical Review tool or similar.
  3. Conduct review of Central Medical Review under guidance of a Central Medical Review and/or Central Monitoring Plan and communicate findings at the site and patient level.
  4. Perform ongoing Central Medical Review for multiple studies under guidance of a Medical Review Plan or any applicable documents and communicate findings at the patient level.
  5. Support team to ensure Critical Data & Process Definition is completed with Data.
  6. Manage and input from project team and supports implementation of critical data focused EDC design.
  7. Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems.
  8. Ensure that tracking and status reporting are performed in a timely and accurate manner and applies data to recommend any patient safety concerns.
  9. Contribute to the Risk Assessment and Categorization Tool for topics related to medical review and considers risks when planning tools configuration.
  10. Support the Data Expert with Critical Data and Process Definition and EDC design implementation.
  11. Draft the Central Medical Review Configuration Plan and maintains this Plan throughout the study including re-versioning as required.
  12. Draft Central Monitoring /Central Medical Review Plans in collaboration with the study team and updates these on an ongoing basis including the refinement of visualizations and any change in data.
  13. Perform ongoing Central Medical Review, discusses findings with the study team.
  14. Collaborate with other Central Monitoring activities to ensure consistency and effectiveness.
  15. Act as subject matter expert based on education qualification/experience.
  16. Provide data-driven decisions and communicate these findings proactively and effectively to the key stakeholders.
  17. Prepare and distribute the quality reports at intervals during study conduct and at study close out.
  18. Ensure filing of study documents in the central files in a central office or hub location.

Qualifications:

  • Medical Doctors (MBBS).
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Language Skills:

Speaking: English required.

Writing / Reading: English required.

Experience:

  • Medical doctors (MBBS) with 1-3 years of experience in medical practice/equivalent clinical research roles.


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