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.
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 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
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
4. 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 comply 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 learnings 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
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
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
• 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
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