Lead, Monitoring Oversight

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Purpose
The purpose of the Lead, Monitoring Oversight role is to be an advocate for monitoring oversight who works with the Clinical Design, Delivery & Analytics (CDDA), the Medicines Quality Organization (MQO) and Investigator Engagement (IE) to ensure that Lilly has appropriate oversight of clinical trial site monitoring activities outsourced to Third Party Organizations (TPOs).

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Conduct Monitoring Visit Report Reviews (MVRRs)

• 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

Escalate Significant Identified Monitoring Oversight Issues

• 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 Monitoring Oversight Trends

• 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)

MVRR Performance Metrics and Process Metrics

• 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

Minimum Qualification Requirements

• 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 related experience
• Knowledge of Good Clinical Practices (GCP) Principles
• Proficient written and spoken English language skills
• Effective verbal communication

Other Information/Additional Preferences

• 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

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