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