Team Leader - 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 35,000 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 Monitoring Oversight Team Leader is responsible for leading and managing a team of Monitoring Oversight Associate Managers and for collaborating with business partners to ensure that L illy has appropriate oversight of clinical trial site monitoring activities outsourced to Third Party Organizations (TPOs). The Monitoring Oversight Team Leader is responsible for recruitment, training and development of the Monitoring Oversight Associate Managers who are responsible for conducting Monitoring Oversight activities inclusive of Monitoring Visit Report Reviews, Monitoring Oversight issue escalation and Monitoring Oversight trends identification.

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.

Monitoring Oversight Responsibilities

• Accountable for meeting Monitoring Oversight targets with a focus on performance and ensuring milestone delivery with quality
• Oversee the collation of information from the appropriate data sources, ensuring this is conducted timely and accurately to meet the required timelines and MVRR targets
• Oversee the site risk assessments analysis for identification of sites to be selected for MVRRs
• Manage communications/relationships and serve as the point of contact for the functions involved in the Monitoring Oversight Process: Site Engagement, Medical Quality Organisation, Clinical Development
• Accountable for distribution and prioritisation of work to ensure the expected MVRR targets are met
• Responsible for review of the work conducted by MO Associate Managers
• Develop and manage strategies to improve customer experience.
• Drive real-time mitigation of issues and appropriate problem solving with proactive approach
• Ensure Inspection Readiness in relation to MO activities

Organizational Leadership

• Provide clear direction and align objectives of the Monitoring Oversight Associate Managers Team with the monitoring oversight plans and targets established by Site Engagement and the Medical Quality Organisation.
• Drive a culture of high quality and inspection readiness
• Continuous monitoring of the performance / productivity of the Monitoring Oversight Associate Managers Team and identification of opportunities for improvement.
• Enable a culture of continuous improvement focused on outcomes, efficiency gains, and individual accountability
• Seek opportunities to identify and apply innovative ideas and/or approaches

People Management and Development

• Effectively manage and coordinate an agile organization that continuously adapts to meet the Monitoring Oversight targets and needs
• Establish performance plans, monitor and evaluate the performance of the Monitoring Oversight Associate Managers
• Attract, develop and retain talent in then organisation

Minimum Qualification Requirements:

• Bachelor’s Degree in a science, technology or medically-related field or equivalent relevant work experience
• 5 years experience in Clinical Trials/Development and good working knowledge of Good Clinical Practice
• Proficient written and spoken English language skills
• Demonstrated leadership skills with ability to influence, achieve results through others and lead across the business.

Other Information/Additional Preferences:

• Strong communication (both verbal and written) and language skills – ability to provide coaching to employees and communicate effectively up and down in the organization
• Demonstrated supervisory skills
• Strong organisational/planning skills
• Strong interpersonal skills
• Demonstrated decision-making ability
• Ability to develop and apply creative solutions
• Experience in working cross-culturally and with virtual teams

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.