Clinical Development Trial Lead

As a Clinical Development Trial Lead (CDTL) at Lilly, you will play a crucial role in leading study teams of internal and external partners to plan and execute studies within the clinical plan. Your primary focus will be on ensuring quality, on-time, and on-budget fulfillment of study deliverables. In addition to your study-related responsibilities, you may also support non-study project assignments aimed at transforming and improving the business. To excel in this role, you will need to seek knowledge from internal and external sources and leverage this information to shape development plans and identify continuous improvement opportunities. Your responsibilities will encompass various aspects of project management, regional operational knowledge, and clinical trial process leadership. You will be responsible for understanding the scope of work required for post-marketing studies/trials, developing and tracking enrollment plans, assessing and monitoring trial-level risks, managing budgets, and coordinating with various stakeholders to ensure the successful implementation and execution of studies. Additionally, you will be accountable for trial/regional enrollment strategy and execution, as well as driving continuous improvement activities based on industry trends and regulatory requirements. In terms of clinical trial process leadership and expertise, you will be expected to demonstrate a deep understanding of the drug development process, coordinate geographic and functional input for study teams, ensure inspection readiness of Trial Master File (TMF) records, and apply global/regional regulations and Good Clinical Practice (GCP) standards in study conduct. Your scientific expertise will be crucial in providing technical consultation for clinical and regulatory documents, influencing clinical trial design and feasibility, and supporting the scientific needs of the business. To qualify for this role, you should have a Bachelor's or University degree in a scientific or health-related field with at least 10 years of clinical research experience or relevant experience. Strong leadership, communication, problem-solving, self-management, and organizational skills are essential for success in this position. Previous experience in cross-functional teams or projects, clinical trial site-level or affiliate experience, and proficiency in project management tools are additional preferences that would be advantageous. At Lilly, we are committed to providing equal opportunities for individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Join us at Lilly and be a part of our mission to make life better for people around the world. #WeAreLilly,