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Eli Lilly And Company
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Lead, Monitoring Oversight

Lead, Monitoring Oversight

Eli Lilly And Company

4 - 9 years

20 - 25 Lacs

bengaluru

Posted:2 weeks ago| Platform:

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Skills Required

gcp manager technology healthcare clinical research site monitoring management research associate analytics monitoring business lead

Work Mode

Work from Office

Job Type

Full Time

Job Description

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)

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Eli Lilly And Company

Pharmaceutical Manufacturing

Indianapolis Indiana

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Lead, Monitoring Oversight