- Location
- Indianapolis
- Type
- Full-time
- Department
- IT
- Seniority
- Director
- Education
- Bachelor
- Closing date
- Today
- Source
- CareersPage
Description
Associate Director, Clinical Development Trial Lead for a top global pharmaceutical company. You'll independently lead cross-functional teams running complex late-phase clinical trials, and you'll be accountable for delivering milestones on time, within scope and on budget.
What you'll do:
- Lead global and regional study teams from startup through execution and closeout
- Own the trial timeline, scope, risks and budget (grants and non-grants)
- Drive enrollment strategy from country allocation through last patient treated
- Serve as the main contact for CROs and other third-party vendors; manage their selection and oversight
- Own the Trial Master File and keep trials inspection-ready at all times
- Detect and resolve quality issues; document deviations and issue summaries
- Provide scientific and regulatory input for clinical documents and regulatory agency questions
- Coach other trial leads and team members; lead process improvements
- Travel occasionally to scientific and regional meetings
Required:
- Bachelor's degree (science or health field preferred)
- 5+ years of clinical research or clinical trial experience
- Strong working knowledge of Good Clinical Practice (GCP) and global and regional regulations
- Experience leading cross-functional and global trial teams and managing CROs
Highly desired:
- Oncology trial experience (early and late phase)
- Project management tools: Veeva, MS Project, Critical Chain, Power BI, Excel
- Prior site-level or country/affiliate experience
- Proven ability to influence without authority and coach others
Skills
GCPExcelPower BIClinical TrialsProject Management