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Job #02963

About our client Our client is a global medical technology company focused on the development and utilization of proprietary technology for advanced wound care, orthopedic, cardiovascular and spine/neurological conditions. Position Location Clinical Trial Leader Atlanta, Georgia Salary Highly competitive package, commensurate with experience Responsibilities 1) Align the efforts of CRAs, Data Management, Biostatistics and medical consultants to create clinical study designs relevant to therapeutic groups 2) Maintain knowledge to represent Clinical Affairs (as needed) 3) Write and coordinate Investigator brochures with team members 4) Coordinate contracts and secrecy agreements for all aspects of assigned clinical trials 5) Develop CRFs and/or coordinate CRF development 6) Oversee technical writing (protocols, Report of Prior Investigations, clinical sections of IDE and PMA) 7) Organize and conduct group Investigator meetings 8) Negotiate financial arrangements with investigators, contractors and/or vendors 9) Develop clinical monitoring plans and provide management with study updates 10) Maintain contact with clinical investigators and staff 11) Conduct reviews and source verification of clinical data 12) Ensure timely resolution of data queries 13) Suggest changes/additions of new processes to the department 14) Provide practical solutions to a wide variety of clinical issues 15) Manage clinical studies for timeliness, cost-effectiveness and adherence to applicable laws and regulations, investigating deviations along with taking corrective action 16) Perform other tasks as assigned Requirements 1) Bachelor’s degree (or higher) 2) 7+ years in clinical research including field-monitoring experience 3) Experience in project management, budgeting 4) Expertise in writing key clinical documents 5) Medical device experience 6) Knowledge of ISO, GCP, ICH, FDA and other regulations governing the conduct of clinical trials 7) Superb technical writing and presentation skills 8) Excellent communication skills in English 9) Ability to interact effectively with others 10) Desire to mentor others 11) Good medical aptitude 12) Ability to be extremely flexible to rapidly changing priorities