G
Full Time Any

Indianapolis, Indiana · USA job

Associate Dir, Clinical Development Trial Lead

Global Channel Management, Inc.

Indianapolis, Indiana

Job description

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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