Clinical Research Lead

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.

We are hiring for two Clinical Research Lead positions to support our clinical trial initiatives:

Ontario-Based Role: This individual will manage clinical sites across Ontario.

Quebec-Based Role: This individual will manage clinical sites in Quebec and must be bilingual (English and French).

Both positions are critical to advancing Lilly's clinical trials and ensuring an exceptional experience for clinical investigators.

Clinical Research Lead (CRL) Overview

The Clinical Research Lead (CRL) is responsible for the management of clinical investigators and sites participating in Lilly clinical trials and Post-Marketing Safety Studies. This includes site identification, qualification, trial enrollment, database lock delivery, and ongoing issues management to ensure inspection readiness at all times. The CRL also provides vendor oversight for site monitoring activities, ensuring timely and high-quality delivery.

Primary Responsibilities

1. Accountable for activities required at clinical trial sites and by investigators and site staff participating in Lilly trials; inclusive of site identification and qualification, enrollment planning and execution, to database lock and close out.
2. Accountable for comprehensive investigator management activities to ensure timely delivery of enrollment readiness, trial recruitment/enrollment, and database locks; inclusive of performance management and issue mitigation, identification, and resolution.
3. Responsible for identifying potential opportunities to accelerate trial enrollment while driving to an unparalleled clinical trial/customer experience.
4. Accountable for the application of scientific, therapeutic area, and institutional/regional expertise to inform and ensure timely delivery of trial enrollment and quality data.
5. Accountable for the development of strategic institutional/site relationships to optimize the delivery of clinical trial programs; including across therapeutic areas where applicable.
6. Responsible for the development and implementation of applicable investigator/site risk plans to ensure delivery of clinical trial enrollment commitments and database locks.
7. Ensure site and country level inspection readiness at all times.
8. Leverage metrics to inform site/country/regional level decision making.
9. Work with internal and external teams to remove barriers to trial execution at a site and/or country level.
10. Responsible for understanding local treatment paradigms and standard of care to support targeted feasibility and strategic allocation of trials as required.
11. Provide vendor oversight for site monitoring activities at site/country level.
12. Establish and develop strong professional relationships with active/potential clinical investigators to expand/maintain clinical research partnership opportunities and provide an unparalleled experience for participation in Lilly clinical trials.
13. Cross-functional collaboration and partnership to ensure alignment in priorities and deliver the portfolio.
14. Perform targeted sites prospecting in alignment with portfolio strategy & priority.
15. Maintain therapeutic and technical expertise to enable scientific discussions with the investigator and site personnel.
16. Serve as an effective communication “bridge” between sites, third party vendors, and Lilly.
17. Influence and challenge internal and external factors in order to improve clinical research delivery.

Qualifications Requirements

1. Bachelor’s degree or equivalent.
2. Minimum of 3 years experience in the pharmaceutical industry and/or clinical research and strong working knowledge of Good Clinical Practice.
3. Therapeutic expertise and knowledge of the clinical research landscape; ability to acquire and maintain therapeutic expertise to support portfolio needs.
4. Strong self-management and organizational skills; ability to manage workload, set personal priorities and adjust as needed.
5. Demonstrated strategic agility & broad business acumen.
6. Demonstrated leadership behaviors with the ability to accept challenges, seek opportunities to remove barriers, influence without authority, and lead in areas of uncertainty.
7. Fluent in English and/or French to conduct day-to-day business in their located region.