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Job #02781

About our client Our client is a publicly traded and fully integrated life science company with close to 400 employees and operations in over 50 countries. The company has enjoyed strong revenue growth and is recognized by multiple leading business journals as a great place to work! Position Location Clinical Trial Manager Ohio Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop and conduct clinical evaluations as well as trials on new and existing product designs 2) Evaluate quality, content and format of US regulatory submissions 3) Communicate with Project Team members, development partners and governmental agencies to ensure that trials and submissions are being managed and conducted appropriately 4) Facilitate open communication with FDA or other relevant governmental organizations to ensure that clinical trial designs meet FDA expectations to prove substantial compliance, safety and effectiveness 5) Organize conference calls or meetings with FDA (as appropriate) 6) Create submission template(s) to ensure consistency in e-submissions 7) Coordinate the assembly, review and submission of regulatory documents such as 510(k), PMA and relative amendments 8) Direct the compilation and review of clinical trial data 9) Assist Project Team in evaluating the effectiveness of clinical trial 10) Apply appropriate statistical techniques to the evaluation of clinical data 11) Interpret and advise the Project Team on the application of governmental regulations and review processes (as appropriate) 12) Oversee development of clinical trial contracts, protocols and training strategies 13) Assist Project Team in identifying appropriate clinical trial sites and testing activities 14) Ensure that clinical trials are initiated, conducted and closed in a timely manner 15) Assist with the compilation of clinical trial data 16) Help in the installation of clinical trial site (as required) 17) Assist with trial site assessment audits (as needed) 18) Direct and mentor personnel as well as clinical studies coordinators in submission practices and regulations 19) Assist with regulatory training programs 20) Provide expertise/guidance to regulatory departments at affiliate companies Requirements 1) BS/BA in Biological Science (MS degree preferred) 2) RAC certification preferred 3) 3 years of experience in regulatory affairs and/or clinical trial management (or equivalent experience in an FDA-regulated industry) 4) Experience in preparing 510(k) documents and applications 5) Experience in managing clinical trial sites and clinical trial data 6) Working knowledge of US federal regulations applicable to IVDDs 7) Ability to manage projects, motivate team members, assign tasks and manage timelines 8) Ability to perform statistical analyses 9) Demonstrated ability to write on scientific or regulatory subjects in a clear and concise manner 10) Ability to communicate clearly and effectively with peers and governmental representatives