Clinical Project Manager

20+ years experience in health and medical fields including pharmacy, urology, cardiology, orthopedics, surgical instruments and dental products with clinical study experience, first as a research coordinator in an academic setting and then industry experience developing and executing pre- and post-market clinical studies along with other aspects including:

  • clinical strategy development
  • study budgets and clinical trial agreements
  • IRB submissions
  • writing of clinical study protocols, informed consent forms and study plans (e.g. data management, study training, etc.)
  • case report form (CRF) design
  • electronic data capture (EDC) creation
  • site screening and selection
  • site activation and closure visits
  • design training materials and study tools
  • study monitoring
  • study site management
  • study training
  • data analysis
  • clinical study report writing
  • literature searches
  • FDA audit prep and support
  • vendor management