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 Job #02837 Email this job to a friend
About our client
Our client is a leading medical device company specialized in ophthalmology and eye care products. They have over 13,000 employees globally and a reputation as a leading innovator in the field. With operations in 36 countries and a 150-year track record of success, this is a great situation for a candidate that is pursuing a challenging opportunity with a world-class employer.
Position Location
Manager, Clinical Research (Pharmaceutical) New York
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Participate with (pharmaceutical) project development teams and contribute to development of clinical strategy as well as field clinical study protocol/reports to support strategy
2) Present clinical results internally, in professional literature and at professional conferences
3) Participate in the development of clinical and commercial strategies, including evaluation of new business opportunities
4) Coordinate with project management and clinical operations to ensure that clinical timelines are met
5) Participate in (pharmaceutical) R&D teams as a clinical representative
6) Manage scientific aspects of pharmaceutical clinical trials independently
7) Ensure compliance with FDA regulations, GCP and ICH guidelines
8) Develop field clinical protocols
9) Participate in Investigator recruitment
10) Identify and evaluate clinical issues related to project and implementation resolutions
11) Interpret clinical data and contribute to clinical reports
12) Provide input on departmental decisions related to process and procedures
Requirements
1) OD or MD with Ophthalmic focus
2) 5 – 7 years of clinical research experience with minimum 3 years of experience in handling Phase IV clinical trials
3) Clinical glaucoma and/or dry eye experience
4) Experience/training in GCP, ICH and/or FDA pharmaceutical regulations a plus
5) Demonstrated ability to train study personnel and study CRAs
6) Ability to manage multiple projects simultaneously
7) Excellent communication, organizational and writing skills

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