Sr. Clinical Trial Project Manager

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.    (Sr.) Manager/Lead- Clinical Development Trial Lead (CDTL) P2-3 Purpose: The Clinical Development Trial Lead (CDTL) leads the cross-functional study team in the development and execution of clinical trials and is accountable both regionally (Including) and globally to deliver trial(s) with quality, on time, and within scope and budget. The senior CDTL Manager/Lead 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 deliverables.

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. Clinical Trial Level Project Management §  Use project management skills, processes and tools to develop and execute 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 trial enrollment plan 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 overall budget 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 actively participate in Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs).§  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 (LPET)§  Partner with Regional Operations 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 CPM Organization, Regional Clinical Operations, 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 important trends such as industry, regulatory, new technology, etc.§  Manage TPO qualification process, selection, and oversight. roved version.  §§  Lead study team to