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Senior Clinical Project Manager (Chicago, IL)

CEDENT

Responsibilities

  • Contribute to our cutting-edge radiopharmaceutical development program
  • Conceptualize, plan, design, place, execute, and summarize clinical trials
  • Drive daily vendor and site management, including collaboration with Study Medical Monitor and KOLs to determine the medical and scientific needs
  • Effectively communicate project-related information including the planning and execution of meetings and presentations as well as creation and maintenance of metrics, e.g., dashboards, timelines, resources, and budgets
  • Contribute to regulatory filings (e.g., IND / IMPD / CTN, NDA)
  • Identify issues and propose solutions. Proactively assess potential risks to the clinical study and propose mitigation plans
  • Work in an office (Wilmette, IL north of Chicago) with a dynamic, talented team

Qualifications

MINIMUM EXPERIENCE

  • Biotech or Pharma company clinical operations experience in progressively responsible positions, including Senior/Clinical Project or Trial Manager
  • 7+ years’ experience managing clinical trials including study design and initiation, oversight, study closeout, project management, and regulatory filings
  • Demonstrated ability to plan and execute Pharma-Sponsored clinical trials, managing vendors and resources in effective & creative manners to achieve business needs including on-time, on-budget, and on-spec study results for successful use in regulatory marketing applications
  • Thorough knowledge of ICH-GCP, Food and Drug Administration (FDA), and European regulations
  • Excellent communication (oral and/or written), leadership, and risk mitigation skills plus a positive attitude
  • Require minimal guidance; is able to function in an independent manner
  • Proven ability to effectively manage internal and external personnel in clinical trial conduct

PREFERRED EXPERIENCE

  • 9 years’ clinical trials experience in pharmaceutical or biotechnology firms
  • Experience in oncology trials
  • Experience managing clinical trials in Europe and/or Australia
  • Experience in a small or growth-stage biopharma company

Vacancy posted more than 2 months ago
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