Healthcare Specialist

6 days ago

Bengaluru, Karnataka, India beBeeClinical Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Medical Reviewer Role

The Medical Reviewer plays a pivotal role in ensuring the highest level of quality and consistency in medical data, with a strong emphasis on patient safety, protocol adherence, and compliance with Good Clinical Practice (GCP), ICH guidelines, and local regulations.

This position requires close collaboration with study team members, including Data Managers, Trial Managers, and Medical Specialists, throughout the trial process. The Medical Reviewer must provide timely updates on the status of medical reviews and escalate any issues to maintain trial integrity and compliance.

  • Key Responsibilities:
  • Collaborate closely with study team members to ensure smooth trial operations.
  • Provide regular updates on medical review status and address any emerging issues.
  • Participate in trial planning activities related to medical review.
  • Perform quality check measures for medical reviews.
  • Resolves issues of medical concern and inconsistencies in clinical trial data with investigational site staff.
  • Presents findings of medical reviews to relevant Medical Specialists for informed decision-making.
  • Documented medical reviews in the sponsor's TMF.
Qualifications and Skills
  • A graduate degree in Medicine or a related field is essential (MBBS, MD).
  • At least 3 years of experience in Clinical Drug Development, Medical Data Review, Medical Monitoring, Investigator, Safety Surveillance, or Scientific Clinical Drug Development is preferred.
  • Strong project management skills are necessary.
  • Familiarity with ICH guidelines and GCP principles is required.
  • Proficient in computer applications, including MS Office, MS Project, and PowerPoint.
  • Excellent grasp of medical terminology and clinical trial processes.
  • Demonstrated analytical skills with a results-oriented approach.
  • Exceptional proficiency in written and spoken English.

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