G
Full Time Any

Indianapolis, Indiana · USA job

Associate Director, Clinical Development Trial Lead

Global Channel Management, Inc

Indianapolis, Indiana

Job description

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 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

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