globalchannelmanagementIndianapolis, IN
Associate Director, Clinical Development Trial Lead
Associate Director, Clinical Development Trial Lead
Research and Development in BiotechnologyResearch and Development in the Physical, Engineering, and Life SciencesPharmaceutical Preparation Manufacturing
Apply for this role (opens in a new tab)Job 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 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
Also on the board Same function, level within a rung
Level
Manager
Location
Indianapolis, IN
Occupation
Clinical Research Coordinators
Industry
Research and Development in Biotechnology
Posted
yesterday