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Senior Clinical Project Manager

CEDENT

Chicago, IL

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JOB DETAILS
SKILLS
Biotech and Pharmaceutical, Budget Management, Budgeting, Clinical Trial, Clinical Trial Management, Communication Skills, FDA (Food and Drug Administration), GCP (Good Clinical Practices), ICH Regulations, Identify Issues, Leadership, Marketing Software, Metrics, Oncology, Presentation/Verbal Skills, Project Close-Out, Project/Program Management, Regulations, Regulatory Submissions, Reporting Dashboards, Resource Management, Risk Analysis, Risk Management, Time Management, Vendor/Supplier Management
LOCATION
Chicago, IL
POSTED
30+ days ago

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

About the Company

C

CEDENT

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