Associate, Monitoring Oversight
Eli Lilly
- Bangalore, Karnataka
- Permanent
- Full-time
- Collate output from multiple data sources and conduct site risk assessments
- Identify sites to be selected for MVRRs based on a predefined set of risk criteria
- Prepare documentation for MVRR review
- Review a sampling of Monitoring Visit Reports (MVRs) produced by TPO Clinical Research Associates (CRAs) following the conduct of monitoring visits at clinical trial sites
- Identify any MVR issues, gaps and required next steps and document this information in a MVRR Checklist
- Record identified MVR issues in the Clinical Trial Management System
- Follow-up with TPO CRA to ensure that any required follow-up actions are completed in a timely manner
- Communicate key detected issues and required next steps to the CRL and/or CDTL for the trial
- Responsible for Inspection Readiness activities in relation to the MO process
- Communicate significant monitoring oversight issues detected during MVRRs to the CRL and/or CDTL for the trial
- Follow-up as needed with the CRA, TPO Management and Lilly Study Teams to discuss the steps required to resolve the detected significant monitoring oversight issues
- Identify and track any monitoring oversight trends that are occurring across sites monitored by the same CRA or across multiple sites or studies monitored by the same TPO
- Discuss any detected monitoring oversight trend(s) with the Monitoring Oversight Business Lead and Medical Quality to determine the next steps required to address the trend(s)
- Identify and track relevant monitoring data to support monitoring oversight of MVRRs
- Follow-up as needed with Lilly Site Engagement and TPO management to discuss the steps required to resolve the detected MVRR performance metrics and process metric issues
- Bachelor’s Degree in a science, technology or medically-related field or equivalent relevant work experience
- At least 2-3 years of clinical research related experience
- Knowledge of Good Clinical Practices (GCP) Principles
- Proficient written and spoken English language skills
- Effective verbal communication
- Ability to work independently and as part of a team
- Previous on-site/remote CRA or monitoring report review experience
- Effective organization/self-management skills
- Excellent problem-solving skills and initiative