Clinical Research Lead, Investigator Engagement-West Coast US ID-2031

November 29, 2024

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

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$111,000 - $162,800

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 and 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, demonstrating of information/tools to make/have informed decisions and discussions, and high-quality interactions with global clinical trial sites to aim to an unparalleled customer experience. The CRL is also responsible for oversight of vendor monitoring activities at clinical trial sites, including the identification, mitigation and critical issue of significant findings and trends.

Responsibilities:

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. Advise 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 striving to an unparalleled clinical trial/customer experience
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 advise 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 oversight for site monitoring activities at site/country level
For countries with PMS requirements: Responsible for Post-Marketing Safety Study management including CRO selection, Regulatory Document Development, and Project Management in compliance with local requirement as required.

Business Management and Engagement

Establishes and develops 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.
Perform targeted sites prospecting in alignment with portfolio strategy & priority
Maintain therapeutic and technical expertise to enable scientific discussions with the investigator and site personnel
Serve as an effective communication “bridge” between sites, third party vendors and Lilly
Influence and challenge internal and external factors in order to improve clinical research delivery
Country / Regulatory (where required in countries where Associate Director / Director Investigator Engagement is not located)
Influence and engage with Regulatory bodies, Ethical Review Boards and other National Authorities to represent Lilly Investigator Engagement in the country Clinical Trial environment(s).
Engage and influence within Country Pharmaceutical Associations / Affiliated bodies.
Ensure internal processes and procedures are maintained to reflect and align with country requirements. Share with other functions as appropriate and ensure local procedures are maintained.
Engage in the external clinical development community to influence improvements, and drive the incorporation of findings into internal improvement efforts and strategy
Engage with affiliate leadership in support of the Associate Director / Director Investigator Engagement to ensure implementation of affiliate and regional initiatives

Basic Qualifications:

Bachelor’s degree or equivalent
Minimum of 3 years experience in the pharmaceutical industry and/or clinical research and strong working knowledge of Good Clinical Practice
Therapeutic expertise and knowledge of the clinical research landscape; ability to acquire and maintain therapeutic expertise to support portfolio needs
Strong self-management and organizational skills; ability to manage workload, set personal priorities and adjust as needed
Strong communication skills (both verbal and written), language proficiency, and ability to influence others
Demonstrated strategic agility & broad business acumen
Demonstrated leadership behaviors with ability to accept challenges, seek opportunities to remove barriers, influence without authority, and lead in areas of uncertainty

Clinical Research Lead, Investigator Engagement-West Coast US ID-2031

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DISCLAIMER

Other Jobs You May Be Interested In

Clinical Research Lead, Investigator Engagement-West Coast US ID-2031

Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

5. HOW DO YOU PROCESS INFORMATION?

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

8. HOW TO PRIORITIZE WORK?

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

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