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Clinical Research Manager
* Review study specific plans and Informed Consent templates.
* Track clinical supplies usage and inventory.
* Insures clinical supplies are shipped to investigational sites.
* May assist in updating of the Investigator’s Brochure and final study reports for assigned protocols.
* Documents and maintains all relevant site communications.
* Reviews tables, listings, and study reports for assigned protocols.
* May be the lead monitor on assigned protocols and/or projects.
* Reviews literature as required.
* Prepares timely reports on the status of clinical trials.
* Degree in Nursing (R.N. or B.S.N), Life Sciences (B.S. or B.A.), Pharmacy or Medicine required
* Minimum of 4+ years of progressively increasing clinical research experience within the pharmaceutical industry. Prior experience in small biotech environment is highly desirable.
* Ophthalmic experience is not required but desirable
* Exposure to Japanese business protocol preferred.
* Thorough understanding of FDA regulations, ICH Guidelines and GCPs.
* Exceptional planning and problem solving skills.
* Demonstrated ability to be comfortable working in a complex, competitive and sometimes not well defined work environment.
* Exceptional communication skills; ability to communicate effectively with all levels of the organization.
* Proficiency in Excel, Word, PowerPoint, Share Point and MS Project.
To apply for this position, please visit
BioTech FYI Center