Senior Associate / Manager, Clinical Development Trial Lead (CDTL)
Eli Lilly and Company
6 hours ago
Remote friendly (Indianapolis, IN)
United States
Clinical Research and Development
Purpose
- The Clinical Development Trial Lead (CDTL) Associate leads cross-functional study teams to develop and execute clinical trials, delivering trial(s) with quality, on time, within scope and budget (regionally and globally).
Responsibilities
- Develop, execute, and deliver local, regional and/or global clinical trials; understand scope and adjust via change control to meet deliverables.
- Timeline: develop and track global milestones across functions and geographies.
- Risk: assess, identify, and monitor trial-level risks; create an integrated risk mitigation/contingency plan.
- Budget: manage trial-level grants/non-grants and assumptions using financial tracking tools; network on budget status/changes.
- Coordinate Investigator Study Specific Training (ISSTs), Affiliate Study Training (ASTs), and Investigator Engagement Meetings.
- Coordinate study teams through implementation, execution, and closure (issue management, contingency planning, issue resolution).
- Own trial/regional enrollment strategy and execution from country allocation through LPET; partner with Investigator Engagement to meet enrollment goals.
- Serve as single point of contact and central owner for trial communication (Clinical Design and Delivery, cross-functional team members, and Third Party Organizations).
- Solve daily issues with cross-functional teams (including vendors and affiliates/regions).
- Support continuous improvement activities based on industry/regulatory/new technology trends.
- Manage TPO qualification, selection, and oversight.
- Apply drug development/process expertise; coordinate regional input and ensure Trial Master File is current and inspection ready.
- Apply GCP/global-regional regulations and Lilly standards; liaise to understand local regulatory requirements.
- Use scientific/regulatory knowledge to consult on clinical/regulatory documents and draft responses for regulatory meetings.
- Impact clinical trial design, feasibility, implementation, and execution; support scientific needs via problem-solving/critical thinking.
Minimum Qualifications
- Bachelor’s or University degree (scientific/health-related preferred).
- 3 years clinical research or relevant clinical trial experience (scientific/health-related) OR an advanced degree.
Highly Desired Skills
- Trial execution methodology/process/tools.
- Cross-cultural work with global colleagues and TPOs.
- Influence without authority; leadership and networking in cross-functional/cross-cultural teams.
- Effective communication, self-management, and organizational skills.
- Ability to manage complex situations (problem-solving, critical thinking, navigating ambiguity).
- Flexibility to adjust to changing priorities.
Other Information
- Periodic travel to AST/ISST/Investigator Engagement meetings and possibly other scientific/regional symposiums.
Benefits (explicitly stated)
- Company bonus (for full-time equivalent employees, depending on performance).
- Eligible for 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance/death benefits; time off/leave; well-being benefits (e.g., employee assistance, fitness benefits).
- Anticipated wage: $65,250 - $148,500.
Application Instructions
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- The Clinical Development Trial Lead (CDTL) Associate leads cross-functional study teams to develop and execute clinical trials, delivering trial(s) with quality, on time, within scope and budget (regionally and globally).
Responsibilities
- Develop, execute, and deliver local, regional and/or global clinical trials; understand scope and adjust via change control to meet deliverables.
- Timeline: develop and track global milestones across functions and geographies.
- Risk: assess, identify, and monitor trial-level risks; create an integrated risk mitigation/contingency plan.
- Budget: manage trial-level grants/non-grants and assumptions using financial tracking tools; network on budget status/changes.
- Coordinate Investigator Study Specific Training (ISSTs), Affiliate Study Training (ASTs), and Investigator Engagement Meetings.
- Coordinate study teams through implementation, execution, and closure (issue management, contingency planning, issue resolution).
- Own trial/regional enrollment strategy and execution from country allocation through LPET; partner with Investigator Engagement to meet enrollment goals.
- Serve as single point of contact and central owner for trial communication (Clinical Design and Delivery, cross-functional team members, and Third Party Organizations).
- Solve daily issues with cross-functional teams (including vendors and affiliates/regions).
- Support continuous improvement activities based on industry/regulatory/new technology trends.
- Manage TPO qualification, selection, and oversight.
- Apply drug development/process expertise; coordinate regional input and ensure Trial Master File is current and inspection ready.
- Apply GCP/global-regional regulations and Lilly standards; liaise to understand local regulatory requirements.
- Use scientific/regulatory knowledge to consult on clinical/regulatory documents and draft responses for regulatory meetings.
- Impact clinical trial design, feasibility, implementation, and execution; support scientific needs via problem-solving/critical thinking.
Minimum Qualifications
- Bachelor’s or University degree (scientific/health-related preferred).
- 3 years clinical research or relevant clinical trial experience (scientific/health-related) OR an advanced degree.
Highly Desired Skills
- Trial execution methodology/process/tools.
- Cross-cultural work with global colleagues and TPOs.
- Influence without authority; leadership and networking in cross-functional/cross-cultural teams.
- Effective communication, self-management, and organizational skills.
- Ability to manage complex situations (problem-solving, critical thinking, navigating ambiguity).
- Flexibility to adjust to changing priorities.
Other Information
- Periodic travel to AST/ISST/Investigator Engagement meetings and possibly other scientific/regional symposiums.
Benefits (explicitly stated)
- Company bonus (for full-time equivalent employees, depending on performance).
- Eligible for 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance/death benefits; time off/leave; well-being benefits (e.g., employee assistance, fitness benefits).
- Anticipated wage: $65,250 - $148,500.
Application Instructions
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation