New job I'm hiring a DIRECTOR OF CLINICAL AFFAIRS - it's a great place to work - spread the word!

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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 DIRECTOR OF CLINICAL AFFAIRS - it's a great place to work - spread the word! Matt Turner 858.356.6772 posted a job: I'm hiring a DIRECTOR OF CLINICAL AFFAIRS - it's a great place to work - spread the word! "Job: DIRECTOR OF CLINICAL AFFAIRS in Irvine, CA DIRECTOR OF CLINICAL AFFAIRS Simply Biotech specializes in recruiting exclusively for Southern California's biotech and device community. We are currently seeking a Director of Clinical Affairs for a growing Orange County firm.   The Director of Clinical Affairs will be responsible for developing and conducting global clinical trials/studies on products and for ensuring compliance with US Food and Drug Administration (FDA) regulations, internationally recognized standards, and other Regulatory body regulations as applicable. Directs and manages the activities of Clinical Affairs department personnel, as well as external contractors (e.g., clinical research organizations (CROs), regional monitors, and consultants). Responsible for providing accurate and complete data for peer reviewed abstracts and publications. Collaborates with internal departments and external contractors to develop strategies for podium presentations and publications.     Other responsibilities include: * Directs and manages the activities of Clinical Affairs staff. * Develop Clinical Affairs liaisons among clinical site, clinical monitoring, and internal project teams. * Oversee clinical management for premarket trials and post-approval studies, and registry studies, including protocol development/training, CRO management for database management/EDC and biostatistical analysis, site monitoring, and timely reporting. * Ensures timely processing and review of clinical trial documentation including patient data, site files, safety oversight and compliance of overall trial documentation. * Liaison with Marketing and clinical Investigators to support the submission of abstracts and papers regarding company devices for presentations at medical symposia and for publication in peer reviewed journals   The qualified Director of Clinical Affairs will possess the following: * Minimum of 8 years experience is required in clinical research to include multicenter IDE clinical trials, safety surveillance, and clinical team management. 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; 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 leadership, interpersonal, presentation, and technical writing skills .   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/X7KC/2"

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