Company: The company is a foremost provider of imaging systems and healthcare technology solutions. Our products and services are at work in 90 percent of hospitals worldwide.
Location: Upstate New York
Reports To: Director of Clinical
Salary: 150K - $170K
Education: Advanced degree in a scientific or clinical discipline
Requirements: Candidates should have extensive experience designing and managing clinical studies with medical devices including study design, site selection, patient recruitment, and data monitoring. Specific qualifications include: Minimum of 5-8 years of work in the clinical environment including. 3-5 years of clinical studies in the medical device environment. Thorough knowledge of clinical trial design and implementation and strong working knowledge of multiple clinical areas required.
Duties: Clinical Affairs Director will assume management responsibility for strategic planning, design, implementation and execution of clinical programs as well as interpretation of clinical study results, preparation of study summaries and reports for regulatory filings, presentations and publications. This position will assume overall responsibility for the design and implementation of clinical trials to develop or demonstrate medical product safety and efficacy. Specific responsibilities include: Interface with regulatory agencies and oversee clinical documents prepared for regulatory submission. Overseeing the portfolio of clinical studies, providing vision and general direction, supporting problem identification and resolution. Leading the effort to establish sound clinical data in support of product development and commercialization objectives.
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