Associate, Monitoring Oversight

At Lilly we unite caring with discovery to make life better for people around the world We are a global healthcare leader headquartered in Indianapolis Indiana Our employees around the world work to discover and bring life-changing medicines to those who need them improve the understanding and management of disease and give back to our communities through philanthropy and volunteerism We give our best effort to our work and we put people first Were looking for people who are determined to make life better for people around the world 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 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 Bachelors 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 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 Eli Lilly and Company Lilly USA LLC and our wholly owned subsidiaries collectively Lilly are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs If you require an accommodation to submit a resume for positions at Lilly please email Lilly Human Resources Lilly Recruiting Compliance lists lilly com for further assistance Please note This email address is intended for use only to request an accommodation as part of the application process 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 WeAreLilly