Senior Associate / Manager, Clinical Development Trial Lead (CDTL)
Eli Lilly and Company
5 days 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, accountable regionally and globally to deliver trial(s) with quality, on time, within scope, and budget.
Primary Responsibilities
- Develop and track global milestones; understand trial scope and monitor status, making changes per change control.
- Assess, identify, and monitor trial-level risks; create integrated risk mitigation/contingency plans.
- Understand trial-level budget components; create/monitor grants and non-grants and assumptions using financial tracking tools; network with partners on budget status/changes.
- Coordinate Investigator Study Specific Training (ISSTs), Affiliate Study Training (ASTs), and Investigator Engagement Meetings.
- Drive/coordinate cross-functional study team 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 achieve enrollment goals.
- Serve as single point of contact and central owner for trial communication with Clinical Design and Delivery, team members, and Third Party Organizations (TPOs).
- Problem-solve daily cross-functional issues; identify continuous improvement opportunities.
- Manage TPO qualification, selection, and oversight.
Clinical Trial Process Leadership
- Demonstrate understanding of drug development process; expand clinical trial process expertise.
- Coordinate regional input using the global/regional operating model.
- Own Trial Master File accountability; ensure inspection readiness.
- Anticipate trial/regional issues; propose proactive approaches to reduce/mitigate risks.
- Lead/influence in ambiguity; coach peers, teams, and TPOs on process and regional specifics.
- Apply global/regional regulations, GCP, and Lilly standards; understand local regulatory requirements.
Scientific Expertise
- Provide technical consultation for clinical/regulatory documents; support regulatory meetings and draft responses.
- Apply clinical trial operational and process expertise to impact trial design, feasibility, implementation, and execution.
Minimum Qualifications
- Bachelor’s degree (scientific/health-related preferred).
- 3 years clinical research or relevant clinical trial experience (or advanced degree).
- Authorized to work in the United States full-time; Lilly does not sponsor visas/work authorization.
Highly Desired Skills
- Trial execution methodology/process/tool knowledge.
- Cross-cultural experience with global colleagues and TPOs.
- Ability to influence without authority; strong leadership/networking.
- Effective communication, self-management, and organization.
- Problem-solving/critical thinking; flexibility with changing priorities.
Other Information
- Periodic travel to AST/ISST/Investigator Engagement meetings and related symposiums.
The Clinical Development Trial Lead (CDTL) Associate leads cross-functional study teams to develop and execute clinical trials, accountable regionally and globally to deliver trial(s) with quality, on time, within scope, and budget.
Primary Responsibilities
- Develop and track global milestones; understand trial scope and monitor status, making changes per change control.
- Assess, identify, and monitor trial-level risks; create integrated risk mitigation/contingency plans.
- Understand trial-level budget components; create/monitor grants and non-grants and assumptions using financial tracking tools; network with partners on budget status/changes.
- Coordinate Investigator Study Specific Training (ISSTs), Affiliate Study Training (ASTs), and Investigator Engagement Meetings.
- Drive/coordinate cross-functional study team 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 achieve enrollment goals.
- Serve as single point of contact and central owner for trial communication with Clinical Design and Delivery, team members, and Third Party Organizations (TPOs).
- Problem-solve daily cross-functional issues; identify continuous improvement opportunities.
- Manage TPO qualification, selection, and oversight.
Clinical Trial Process Leadership
- Demonstrate understanding of drug development process; expand clinical trial process expertise.
- Coordinate regional input using the global/regional operating model.
- Own Trial Master File accountability; ensure inspection readiness.
- Anticipate trial/regional issues; propose proactive approaches to reduce/mitigate risks.
- Lead/influence in ambiguity; coach peers, teams, and TPOs on process and regional specifics.
- Apply global/regional regulations, GCP, and Lilly standards; understand local regulatory requirements.
Scientific Expertise
- Provide technical consultation for clinical/regulatory documents; support regulatory meetings and draft responses.
- Apply clinical trial operational and process expertise to impact trial design, feasibility, implementation, and execution.
Minimum Qualifications
- Bachelor’s degree (scientific/health-related preferred).
- 3 years clinical research or relevant clinical trial experience (or advanced degree).
- Authorized to work in the United States full-time; Lilly does not sponsor visas/work authorization.
Highly Desired Skills
- Trial execution methodology/process/tool knowledge.
- Cross-cultural experience with global colleagues and TPOs.
- Ability to influence without authority; strong leadership/networking.
- Effective communication, self-management, and organization.
- Problem-solving/critical thinking; flexibility with changing priorities.
Other Information
- Periodic travel to AST/ISST/Investigator Engagement meetings and related symposiums.