Clinical Development Trial Lead

Associate - Clinical Development Trial Lead

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.

Purpose :

The Associate - Clinical Development Trial Lead (CDTL) 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 leverages 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 objectives.

Trial Leadership, and Regional Operational Knowledge

• Use processes and tools to develop, implement, 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 (per change control process) 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 financial tracking tools. Routinely network with appropriate business partners, on trial-level budget status and changes.
• Partner with other organizations to coordinate and deliver Investigator Study Specific Training (ISSTs) / Affiliate Study Training (ASTs) / 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 resolving issues.
• Be accountable for trial / regional enrollment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET)
• Partner with the Investigator Engagement organization to achieve regional enrollment goals.
• Manage 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 Vendors.
• 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 improvement activities based on important trends such as industry, regulatory, new technology, etc.
• Manage vendor qualification process, selection, and oversight.

Clinical Trial Process Leadership and Expertise

Scientific Expertise

Minimum Qualification Requirements :

Highly Desired Skills :

Other Information / Additional Preferences :