A global research consulting group providing 360° support & services across all facets of clinical outcomes research.
Principal Clinical Data Manager
Location
United States
Posted
27 days ago
Salary
Not specified
Job Description
Job Requirements
- MS or BS in health-related, life sciences area or technology-related field.
- Minimum of 10 years data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
- Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
- Experience with all phases of development in one or more therapeutic areas preferred.
- Ability to handle multiple development programs simultaneously.
- NDA/CTD Experience preferred.
- Strong knowledge of data management best practices & technologies as applied to clinical trials.
- Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
- Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
- Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.
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