
Clinical Oversight Lead
7 hours ago
Job Title: Clinical Oversight Lead
About the RoleThe 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
- 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
- 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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