Associate Director, Clinical Development Trial Lead

Globalchannelmanagement
  • Indianapolis, IN
    12 days ago

    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 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

    Numbers & Facts

    LocationIndianapolis, IN

    Skills

    • Biotech and Pharmaceuticalunmatched
    • Budget Managementunmatched
    • Budgetingunmatched
    • Clinical Practices/Protocolsunmatched
    • Clinical Researchunmatched
    • Clinical Study Publicationsunmatched
    • Clinical Trialunmatched
    • Coachingunmatched
    • Contract Research Organization (CRO)unmatched
    • Cross-Functionalunmatched
    • Drug Developmentunmatched
    • GCP (Good Clinical Practices)unmatched
    • Health Scienceunmatched
    • Leadershipunmatched
    • Microsoft Projectunmatched
    • Oncologyunmatched
    • Power BIunmatched
    • Problem Solving Skillsunmatched
    • Process Improvementunmatched
    • Project Management Softwareunmatched
    • Regulationsunmatched
    • Startupunmatched
    • Team Lead/Managerunmatched
    • Time Managementunmatched

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