Clinical Research Lead

1 month ago

Sydney, Australia Lilly Full time

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.

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.

**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.

**1. 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 development of strategic institutional/site relationships to optimize the delivery of clinical trial programs; including across therapeutic areas where applicable

**2. 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 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.

**3. 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.
- Cross functional collaboration and partnership to ensure alignment in priorities and deliver the portfolio
- 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

**Minimum Qualification Requirements**:

- 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 person

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