Manager, Clinical Development Trial Lead

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.

At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered.

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** THIS IS ROLE IS REQUIRED TO SIT ONSITE (HYBRID-MODEL, 3 DAYS/WEEK) AT OUR CORPORATE CENTER LOCATED IN INDIANDAPOLIS, IN. RELOCATION SUPPORT WILL BE PROVIDED FOR CANDIDATES REQUIRING FINANCIAL ASSISTANCE.

Note:

Roles are posted at the lowest level of a band, however, employees should search across all levels of the band to identify all opportunities. Employees hired on banded positions (ex: P1-P3, R1-R2, B1-B3, etc.) transfer at their current level, despite the level indicated on the job posting. For example, if a P2 candidate is selected for a P1-P3 banded position, the candidate will remain a P2 in the new role.

The Manager, 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 / Manager 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.

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 supervision regarding your actual job responsibilities and any related duties that may be required for the position.

• 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 global trial enrolment 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…