Description
Essential Job Functions:- Manages overall operation of the entire clinical study including project planning, budget, resource management and CRO management
- Directs the design, documentation, testing and implementation of clinical data collection studies, external reproducibility studies and clinical database review
- Ensures GCP ICP regulatory compliance
- Develop and manage clinical budget and contingency plans for clinical trials
- Manage full scope of study, protocol, including site initiation and closeout
- Acts as a cross-functional liason to ensure study plans aligns with business development strategies
- Manages clinical sample procurement for the company
Requirements:
- B.S. in a scientific discipline
- 5+ years experience in clinical affairs (medical device; IVD)
- Cardiology experience highly preferred
- Experience with CRO/ vendor management
- Experience with CE Marking and EU trials is highly desirable
- Up to 25% travel required (global and domestic)
To find out more about Real please visit www.realstaffing.com