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US-Seattle-Washington: Clinical Research Manager

Date: 03-Apr-2012
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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.

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BioTech FYI Center