
Lead, Monitoring Oversight
4 days ago
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 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
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 ) 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.
#WeAreLilly
-
Lead, Monitoring Oversight
1 day ago
Bengaluru, Karnataka, India Lilly Full timeJob DescriptionPurpose: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...
-
Clinical Oversight Lead
21 hours ago
Bengaluru, Karnataka, India beBeeClinicalOversight Full time ₹ 50,00,000 - ₹ 1,00,00,000Job Title: Clinical Oversight LeadAbout the RoleThe Clinical Oversight Lead is responsible for ensuring effective clinical trial site monitoring activities. This role works closely with cross-functional teams to ensure Lilly has appropriate oversight of outsourced clinical trial site monitoring.Main Responsibilities:Conduct regular review of Monitoring Visit...
-
Alternative Oversight Associate
3 weeks ago
Bengaluru, Karnataka, India JP Morgan Chase Full time: Join our team in Bangalore and work closely with our Luxembourg-based team to ensure the highest standards of oversight and compliance. Be a part of a global organization that values innovation, collaboration, and excellence. As an Alternative Oversight Associate within the Product Administration team, you will conduct risk-based oversight controls on...
-
Lead Monitoring
3 weeks ago
Bengaluru, Karnataka, India Orange Full timeabout the role We are looking for an experienced Monitoring and Observability System Architect to join our team and onboard in the NewCo program an exciting project to enhance Orange Business operational efficiency and customer experience by delivering a greenfield OSS BSS and service assurance IT stack The position is hosted within the Digital...
-
Strategic Risk Oversight Leader
2 days ago
Bengaluru, Karnataka, India beBeeRisk Full time ₹ 1,43,49,165 - ₹ 2,09,49,570Job OverviewWe are seeking a seasoned professional to lead our Model Risk Management team, providing strategic vision and leadership to ensure robust model risk oversight and best-in-class validation function across the organization.The ideal candidate will oversee comprehensive model validation and review processes in accordance with industry-recognized...
-
Lead Monitoring
2 days ago
Bengaluru, Karnataka, India Orange Business Full timeAbout usOrange Business is a network and digital integrator that understands the entire value chain of the digital world, freeing our customers to focus on the strategic initiatives that shape their business. Every day, you will collaborate with a team dedicated to providing consistent, sustainable global solutions, no matter where our customers operate....
-
Senior Clinical Project Manager
8 hours ago
Bengaluru, Karnataka, India beBeeLeadership Full time ₹ 60,00,000 - ₹ 1,20,00,000Job Overview:The Centralized Monitoring Lead is responsible for overseeing the delivery of project objectives to sponsor satisfaction. The role entails optimizing speed, quality, and cost of delivery in accordance with standard operating procedures, policies, and practices.Key Responsibilities:Oversight of clinical deliverables across all trial phases...
-
Associate-inter Affiliate Oversight
4 weeks ago
Bengaluru, Karnataka, India JPMorgan Chase Full timeJob Category Operating Risk Control Mgt The Inter Affiliate Services team is a centralized group within Global Supplier Services that manages the Inter Affiliate Oversight Governance function for several different Corporate Functions in the regions This group provides consistent monitoring of all Inter Affiliate activity between JPMC legal entities...
-
Financial Project Oversight Specialist
21 hours ago
Bengaluru, Karnataka, India beBeeProject Full time ₹ 1,50,00,000 - ₹ 2,00,00,000Financial Project Oversight RoleWe are seeking a skilled professional to manage the financial aspects of our projects.Responsibilities:In coordination with the Project Manager, prepare periodic project reviews with relevant financial analysis and projections.Closely involve with the Project Manager to control and optimize project results, ensuring timely...
-
Project Oversight Specialist
3 days ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000Project Oversight SpecialistWe are seeking a seasoned professional to manage complex projects in a highly regulated environment.This role is pivotal in ensuring timely and successful project delivery, aligned with established objectives and regulatory requirements.The successful candidate will lead strategic initiatives, drive continuous improvement, and...