Manager, Clinical Development Trial Lead (CDTL)

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.  R-82730 Associate/Sr. Associate/Manager, Clinical Development Trial Lead (CDTL) Position Summary: The Clinical Development Trial Lead (CDTL) Associate/Sr. Associate/Manager leads the cross-functional study team in the development and execution of clinical trials and is accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget. The CDTL Associate uses project management, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive actions and coordinate efforts to achieve or exceed these trial deliverables.

Trial Leadership, and Regional Operational Knowledge: Use processes and tools to develop, execute, and deliver local, regional and/or global clinical trials as described below: Scope - Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make changes as needed to meet the deliverables of the trial. Timeline – Develop and track global milestones by gaining alignment and integrating inputs across functions and geographies. Risk - Assess, identify and monitor trial-level risks. Incorporate scientific knowledge, trial process, and regional expertise to create one integrated trial-level risk mitigation and contingency plan. Budget - Understand the cross-functional, trial-level budget components. Create and monitor the grants and non-grants, and assumptions using tracking tools. Routinely network with business partners on trial-level budget status and changes. Partner with organizations to coordinate and deliver training and Investigator Engagement Meetings. Drive and coordinate local, regional and global, cross-functional study team throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution. Be accountable for trial/regional enrollment strategy and execution starting from country allocation through Last Patient Entered Treatment Partner with the Investigator Engagement organization to achieve regional enrollment goals. Handle relationships and serve as a single point of contact and central owner for trial communication, to and from the Clinical Design and Delivery organization, all cross- functional team members, and Third Party Organization (TPOs). Apply problem-solving skills to daily issues with cross-functional study team (including with vendors, affiliates/regions, global team members and other business partners). Identify and assist in developing continuous improvement activities based on meaningful trends such as industry, regulatory, new technology, etc. Handle TPO qualification process, selection, and oversight. Clinical Trial Process Leadership and Expertise Demonstrate understanding of drug development process. Acknowledge inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise. Be knowledgeable of the global and regional operating model; coordinate and facilitate acquiring regional input to provide to the study teams. Single point of accountability for the Trial Master File, working closely with functional record owners to