Medical Data Review

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

  67 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.