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Job #03614

About our client Our client develops medical devices for the aesthetics, ophthalmology and surgical industry. Position Location Director of Clinical Trials California Salary Highly competitive package, commensurate with experience Responsibilities 1) Initiate, manage and complete all global clinical trial activities, ISS studies, and beta evaluations as necessitated by R&D, Regulatory and Marketing 2) Coordinate with R&D, Marketing and Aesthetics management on a clinical strategy 3) Develop and manage all trials by product line and each global region 4) Coordinate with the Regional Marketing Team on all studies 5) Develop and manage associated budgets and publication plan 6) Secure written and signed agreements with each site 7) Coordinate the selection of physicians and sites 8) Ensure collection of Case Report forms 9) Submit final report to department that requested the study 10) Complete IDE application 11) Submit application with all associated documents 12) Follow up with FDA for IDE approval 13) Submit follow-up reports to the FDA and the final report to close IDE 14) Coordinate all activities with the IRB including IRB Selection 15) Submit protocol and obtain IRB approval 16) Coordinate IRB activities with physicians 17) Submit follow up reports to IRB 18) Support clinical publications in conjunction with the marketing team 19) Assist physicians with submission of peer-reviewed articles 20) Ensure physician produces agreed-on output, i.e. White paper, peer-reviewed articles Requirements 1) Bachelor's degree in a scientific discipline or a health-related field 2) Minimum 5 years of experience in the medical device (laser) industry 3) Experienced in getting clinical trials off the ground 4) Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations 5) Working knowledge of MS Office 6) Excellent communication (oral and written) skills and strong organizational abilities 7) Ability to work efficiently independently or in a team environment 8) Ability to monitor sites via visits and follow-up 9) Ability to manage budgets and clinical activities for the global aesthetic business 10) Ability to analyze data obtained in the study 11) Ability to develop protocols, consent corms, IRB submissions and case report forms 12) Ability to develop and manage 3-year clinical plan and coordinate IDE approval from the FDA for significant risk devices 13) Ability to successfully manage trials from beginning to end and IRB Selection