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CLINICAL RESEARCH (Pharmaceutical) - Manager
LOCATION: New York State
SALARY: 110k + relo
Participate on (pharmaceutical) project development teams and
contribute to the development of clinical strategy and field clinical
study protocol/reports to support strategy.
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.
REQUIREMENTS:
Education: OD, MD, or Ph.D.
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.
• MD/OD/PhD (Ophthalmic focus)
• Minimum 3 years Phase IV experience
• Clinical glaucoma and/or dry eye experience
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