Associate Director - Clinical Research Lead, Investigator Engagement - Southeast US

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$111,000 - $162,800

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Purpose:

The Clinical Research Lead (CRL) is responsible for the management of clinical Investigators and sites being considered and/or participating in Lilly clinical trials and / or Post Marketing Safety Studies; inclusive of Investigator / site identification and qualification, the timely delivery of clinical trial enrollment in accordance with scientific objectives, timely delivery of database locks, issues management at clinical trial sites, and ensuring inspection readiness at all times for assigned therapeutic area(s) within a region/country that enables global program delivery. This is achieved by the CRL’s accountability for comprehensive Investigator and site management, leveraging of information/tools to make/have informed decisions and discussions, and high quality interactions with global clinical trial sites to drive to an unparalled customer experience. The CRL is also responsible for oversight of vendor monitoring activities at clinical trial sites, including the identification, mitigation and escalation of significant findings and trends.

Additional local responsibilities may be required as needed/appropriate for the local geography.

In countries where there is not an Associate Director / Director Investigator Engagement located, the CRL may be accountable for representing Investigator Engagement internally and externally with Regulatory and other External Bodies and may be responsible for understanding and influencing the regulatory environment and strategy within the country.

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.

Clinical Investigator Management

• 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
• 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
• Responsible for identifying potential opportunities to accelerate trial enrollment, while driving to an unparalleled clinical trial/customer experience
• Accountable for the application of scientific, therapeutic area, and institutional/regional expertise to inform and ensure timely delivery of trial enrollment and quality data
• Accountable for the development of strategic institutional/site relationships to optimize the delivery of clinical trial programs; including across therapeutic areas where applicable

Clinical Trial Management

• Responsible for the development and implementation of applicable investigator / site risk plans to ensure delivery of clinical trial enrollment commitments and database locks
• Ensure site and country level inspection readiness at all times
• Leverage metrics to inform site/country/regional level decision making
• Work with internal and external teams to remove barriers to trial execution at a site and/or country level
• Responsible for understanding local treatment paradigms and standard of care to support targeted feasibility and strategic allocation of trials as required
• Provide vendor oversigh