Associate, Monitoring Oversight - Bengaluru, Karnataka, India - Lilly

Lilly

Verified Company

Bengaluru, Karnataka, India

3 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

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. We're 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
Followup with TPO CRA to ensure that any required followup 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
Followup 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
Followup 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 medicallyrelated field or equivalent relevant work experience
At least 23 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 onsite/remote CRA or monitoring report review experience
Effective organization/selfmanagement skills
Excellent problemsolving skills and initiative

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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