Senior Manager - Clinical Research Lead (Crl)

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 sites being considered and/or participating in Lilly clinical trials; inclusive of 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 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 unparallel 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.

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 site 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 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

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 in a scientific or health-related field
• Minimum of 5 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
• Demonstrated strategic agility & broad business acumen
• Demonstrated leadership behaviours with ability to accept challenges, seek opportunities to remove barriers, influence without authority, and lead in areas of uncertainty

Other Information/Additional Preferences:

• Strong communication (both verbal and written) and language skills
• Strong organisational/planning skills
• Demonstrated ability to enhance/improve customer experience
• Fluent in English as well as required language to conduct day-to-day business
• Strong knowledge in country regulatory guidelines/requirements
• Strong teamwork and interpersonal skills
• Demonstrated decision-making ability
• Ability to develop and apply creative solutions
• Travel required (50-75%)

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.

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