Clinical Trial Manager

Location:	Burlington, Massachusetts, USA
Job Type:	Permanent
Posted:	11th Mar 2008
Closing Date:	8th Apr 2008
Posted By:	Human Capital Consultants
Details:
Clinical Trial Manager Clinical Trial Manager - Burlington, MA Our client is a privately held company that develops and commercializes medical devices for the treatment of osteoarthritis and joint damages. Our client’s instrumentation enables the creation of novel disposable instrumentation that radically simplifies and improves the surgical process. To date, our client has developed a comprehensive line of minimally traumatic, bone and cartilage-preserving knee implants and instrumentation designed to address all stages of osteoarthritis, the most common reason for knee replacement surgery. Each of these devices has been cleared by the US Food and Drug Administration for marketing in the U.S. Responsibilities: Manage the conduct of current and planned orthopedic clinical trials, including investigator recruitment, managing data flow, clinical quality assurance and data review. Assist in the development and preparation of clinical protocols, with input from medical and technical staff; Develop appropriate case report forms and other study related documents; Act as liaison with IRBs, Ethics Committees, etc. to assure timely compliance with all requirements, approval of new investigational sites, etc.; Act as liaison with outside data management service; Prepare reports, slides, presentation of clinical data as needed Act as liaison with, and supervise, CRO in Europe Qualifications: RN or BA/BS in an appropriate field of study; A minimum of 5 years of clinical research experience (10+ preferred) that includes administrative/site management responsibility; A “hands on” attitude Experience in small company environment a plus Strong computer skills (Microsoft Office) Basic understanding of statistical principles; Strong familiarity with GCP and ICH Guidelines for clinical trials; Ability to work independently in a small company environment; Orthopedic background a strong plus

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