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The Clinical element of drug development encompasses all aspects of the clinical trials process; from first in human studies through submission and drug/device approval (phases 1-4). Experts working in this space usually specialize in certain therapeutic areas, as the study design in some spaces differs to others. There are many individuals involved in the various drug/device development phases, to include Biostatisticians, Medical Directors and Data Managers.
Our specialism breakdown includes:
Clinical Data Management
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Senior Medical Director, Clinical Development
- New Jersey
Duties and Responsibilities Assist in building a team based on the needs of the program Lead junior members of the team and provide mentorship Review clinical and scientific data Draft, develop, and review study protocols and protocol amendments Contribute clinical sections to documents such as the IB, DSUR or IND...
Medical Director, Clinical Development
- New Jersey
Duties and Responsibilities Design and develop clinical plans and protocols Build relationships with principal investigators Review clinical and scientific data Contribute to key interactions with regulatory authorities Develop clinical content for regulatory reports and CSRs Provide regular updates on progress of...
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