Associate Director, Clinical Development Trial Lead

Globalchannelmanagement
  • Indianapolis, Indiana
  • Autofill and Review
8 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, Indiana

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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