Description
Responsibilities:- Manages clinical operational plan, and incorporates the study and scientific plan.
- Ensures the selection of qualified clinical trial sites.
- Develops study related documents and overall direction for the clinical sites to establish protocol development.
- Uses statistical analysis systems, such as SAS, as appropriate.
- Negotiates all aspects of clinical trial agreements.
- Monitors clinical trial sites for compliance and performance.
- Ensures compliance with good clinical practices (GCPs), good manufacturing practices (GMPs) and regulatory guidelines.
- Manages clinical budget and develops contingency plans for clinical trials.
- Oversees clinical trials staff and manages all aspects of clinical operational plan.
- Responsible for managing full scope of study, protocol and clinical report.
- Acts as a cross functional liaison to ensure study plan aligns with business development strategies.
- Selects, develops and evaluates staff to ensure the efficient support for the business function.
Skills / Education:
- Bachelor's degree in a scientific discipline, Masters Degree strongly preferred
- 6 to 10 years of clinical research experience within medical device (IVD preferred), biotech, or pharmaceutical
- Demonstrated management skills and the ability to develop staff
- Excellent organizational and project management skills
- Strong oral and written communication skills; strong technical writing skills
- Working knowledge of FDA regulatory requirements related to clinical research
- Travel requirements up to 20%
- Experience working with infectious diseases is strongly preferred
To find out more about Real please visit www.realstaffing.com