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Purpose:

The purpose of the Associate, 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 assessmentsIdentify sites to be selected for MVRRs based on a predefined set of risk criteriaPrepare documentation for MVRR reviewReview a sampling of Monitoring Visit Reports (MVRs) produced by TPO Clinical Research Associates (CRAs) following the conduct of monitoring visits at clinical trial sitesIdentify any MVR issues, gaps and required next steps and document this information in a MVRR ChecklistRecord identified MVR issues in the Clinical Trial Management SystemFollow-up with TPO CRA to ensure that any required follow-up actions are completed in a timely mannerCommunicate key detected issues and required next steps to the CRL and/or CDTL for the trialResponsible 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 trialFollow-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 TPODiscuss 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 MVRRsFollow-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 experienceAt least 2-3 years of clinical research related experienceKnowledge of Good Clinical Practices (GCP) PrinciplesProficient written and spoken English language skillsEffective verbal communication

Other Information/Additional Preferences:

Ability to work independently and as part of a teamPrevious on-site/remote CRA or monitoring report review experienceEffective organization/self-management skillsExcellent problem-solving skills and initiative

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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