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Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: I'm hiring a CLINICAL PROJECT MANAGER - awesome culture - check out this job Matt Turner 858.356.6772 posted a job: I'm hiring a CLINICAL PROJECT MANAGER - awesome culture - check out this job "Job: CLINICAL PROJECT MANAGER in Irvine, CA CLINICAL PROJECT MANAGER Simply Biotech specializes in recruiting exclusively for Southern Californias biotech and device community. We are currently seeking a Clinical Project Manager for a growing Orange County firm.   The Clinical Project Manager will design, plan and conduct clinical research trials while effectively managing the activities of study investigators, site coordinators, clinical research organizations (CROs), contractors, and regional monitors. Oversees and ensures compliance with study protocols, FDA and International regulations, IRB and/or Ethics committees requirements and overall clinical objectives.     Other responsibilities include: * Under the direction of Senior Manager, Clinical Affairs Sr. Director, Clinical Affairs, implement clinical research projects. * Prepares training materials for study personnel, contractors, and internal staff as appropriate and administers training. * Prepares high quality study protocols and reports. * Prepares high quality presentation materials, abstracts, and manuscripts in concert with physician experts. * Oversees and assigns prioritized tasks to Clinical Affairs specialists. * Manages regional monitors and other contractors per the project requirements. * Oversees all aspects of study conduct, and works closely with site personnel as well as other department members and contractors to ensure protocol and procedure compliance; monitors case report forms, study logs, and data; identify and resolve discrepancies; and recommends corrective and preventive action in a timely manner. * Supports project teams, and has involvement in development of Hazard Analyses and Risk Management documentation. * Evaluates product history data based on customer experience reports, results of controlled investigations and published literature for the device or similar devices, if applicable. * Attend relevant scientific and/or medical meetings. * 30 to 50% travel.   The qualified Clinical Project Manager will possess the following: * Minimum of 5-8 years experience in clinical research. Medical device research experience is strongly preferred. * Requires a Bachelors degree in a scientific discipline, RN or BSN degree or equivalent * Working knowledge of International and US FDA regulatory requirements related to clinical research. * Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors * Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. * Strong interpersonal and technical writing skills * Normally receives limited instructions on routine work, general instructions on new assignments. .   For immediate and confidential consideration, please email your resume to mturner@simplybiotech.com or call 858.356.6772   More information can be found at www.simplybiotech.com http://bull.hn/l/X7MV/2"

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