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Job #03192

About our client Our client is a rapidly growing tissue regeneration company based in Waltham, Massachusetts. They develop and manufacture products that improve the body’s ability to regenerate healthy cartilage, improve joint function and prevent degenerative disease. Recently, they closed a $9M round of equity financing. The financing will be used to further the development and clinical trials of its neocartilage implant and auto-regenerative cartilage matrix. The neocartilage implant will finish Phase II clinical trials this fall where it is showing promise for use as a treatment for repairing knee joints. This is an excellent opportunity for the right candidate to join a fast-paced environment. Position Location Director of Clinical Operations Waltham, Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the development and execution of a strategy to ensure that all clinical study enrollment goals are met and that clinical operations activities are conducted efficiently as well as in compliance with US requirements 2) Develop, implement and support patient recruitment and retention strategies for clinical studies 3) Oversee strategy for study, site feasibility and selection to ensure optimal selection of sites and investigators 4) Develop strategies and field activities to increase productivity and optimize value of clinical projects 5) Liaise regularly with clinical investigators, study coordinators, monitors and other external staff training to ensure timely and quality execution of studies 6) Provide in-service training to surgeons and clinical study staff 7) Advise cross functional teams on recruitment methodologies and recruitment metrics Requirements 1) Technical Degree in Life Sciences or equivalent experience 2) Prior experience in orthopedics or nursing preferred 3) 10 years of direct medical device development/clinical study/clinical sales experience 4) Experience in developing and implementing metrics and clinical study patient recruitment strategies 5) Experience in identifying solutions to recruitment issues and solving problems arising from recruitment 6) Experience in designing and conducting clinical studies and training programs 7) Experience in developing and tracking appropriate metrics to assess clinical operations performance 8) Experience in and comfortable with working in the operating room 9) Familiarity with FDA requirements 10) Proficiency in Microsoft applications 11) Strong analytical, training and mentoring skills 12) Superb communication skills (verbal and written) 13) Attention to detail and accuracy 14) Ability to interface with multiple disciplines 15) Good planning, organizational and project management skills with ability to multi-task