Clinical Oversight Lead

7 hours ago


Bengaluru, Karnataka, India beBeeClinicalOversight Full time ₹ 50,00,000 - ₹ 1,00,00,000

Job Title: Clinical Oversight Lead

About the Role

The Clinical Oversight Lead is responsible for ensuring effective clinical trial site monitoring activities. This role works closely with cross-functional teams to ensure Lilly has appropriate oversight of outsourced clinical trial site monitoring.

Main Responsibilities:
  • Conduct regular review of Monitoring Visit Reports (MVRs)
  • Collate output from multiple data sources and conduct site risk assessments
  • Identify sites to be selected for MVR reviews based on predefined risk criteria
  • Prepare documentation for MVR review
  • Review a sampling of MVRs produced by Third-Party Organization (TPO) Clinical Research Associates (CRAs)
  • Document identified MVR issues in a checklist format
  • Record identified MVR issues in the Clinical Trial Management System
  • Follow-up with TPO CRA to ensure completion of required follow-up actions
  • Evaluate Inspection Readiness activities related to the Monitoring Oversight process
Qualifications and Skills
  • Bachelor's Degree in a science, technology or medically-related field or equivalent relevant work experience
  • At least 4+ years of core clinical research and Monitoring experience
  • Knowledge of Good Clinical Practices (GCP) Principles
  • Excellent written and verbal communication skills
  • Effective problem-solving skills and initiative
Additional Information
  • Ability to work independently and as part of a team
  • Previous experience in Monitoring Report Review or similar roles
  • Strong organizational and self-management skills


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