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Job Description:
Participate on (pharmaceutical) project development teams and contribute to the development of clinical strategy and field clinical study protocol/reports to support strategy.
Job Duties:
Participate on (pharmaceutical) R&D teams as clinical representative. Participate in development of clinical and commercial strategies, including evaluation of new business opportunities. Coordinate with project management and clinical operations to assure that clinical timelines are met. Present clinical results internally, in the professional literature and at professional conferences. Independently manage all scientific aspects of pharmaceutical clinical trials. Ensure compliance with FDA regulations, GCP and ICH guidelines. Develop field clinical protocols. Participate in Investigator recruitment. Identify and evaluate clinical issues related to the project and implementation resolutions. Interpret clinical data and contribute to clinical reports. Provide input on departmental decisions related to process and procedures.
Qualifications
Education:
OD, MD. Experience: Minimum 5-7 years research or related experience. Must have excellent communication, organizational and writing skills.
Special Skills:
Experience with ophthalmic pharmaceuticals for the treatment of glaucoma and dry eye preferred. Demonstrated ability to train study personnel and study CRAs. Ability to manage multiple projects simultaneously. Specialized Training: Experience/training in GCP, ICH and/or FDA pharmaceutical regulations is beneficial.
Work Location NY - Rochester-1400 N Goodman Street
