Associate Director, Clinical Development Trial Lead
global channel managementIndianapolis (IN)
Associate Director, Clinical Development Trial Lead
Posted 9 days ago
global channel managementIndianapolis (IN)
SENIORITY
Manager
About the role
Associate Director, Clinical Development Trial Lead for a top global pharmaceutical company. Youll independently lead cross-functional teams running complex late-phase clinical trials, and youll be accountable for delivering milestones on time, within scope and on budget. What youll 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:
Bachelors 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 CROsHighly desired:
- Oncology trial experience (early and late phase)
- Project management tools: Veeva, MS Project, Critical Chain, Power BI, ExcelPrior site-level or country/affiliate experience
- Proven ability to influence without authority and coach others
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