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Job #02580

About our client Our client is a medical device company founded in the late ’90s to address the unmet need for better, more effective organ transplant technologies. The company is the pioneer in the development of a commercial, portable warm blood perfusion system that allows for a new type of organ transplant, called living organ transplant. This technology helps maintain the organs in a working condition during the transport stage. It supports organ availability and improves results for an increasing number of patients in need of a transplant. The technology decreases the gap between the number of organs available and those awaiting transplants. Position Location Director of Clinical Affairs East Coast Salary Highly competitive package, commensurate with experience Responsibilities 1) Initiate, develop and implement departmental clinical plans 2) Design clinical protocols, methods, data management/analysis plans and clinical trial documents 3) Develop and participate in all aspects of project planning and operations 4) Create and manage project budgets 5) Seek expert opinions and recruit/manage clinical researchers, investigators and associates 6) Work with other groups and departments to achieve company objectives and establish a working team 7) Seek and develop contracts 8) Oversee the outside vendors in clinical research Requirements 1) Bachelor’s degree in Science-related field or equivalent 2) 7 years of experience in clinical trials 3) Minimum of 2 – 3 years of management experience 4) At least 7 years of experience in industry-sponsored clinical research 5) Experience in cardio-thoracic or cardiology preferred 6) Knowledge in strategic planning and implementing clinical trials using internal and external resources 7) Knowledge of departmental policy, SOPs, goals and objectives development 8) Strong knowledge of clinical operation infrastructure establishment, including documentation, clinical trial management systems and clinical database platforms 9) In-depth knowledge of protocol, case report forms and study report development 10) Knowledge of CRO and vendor management 11) Hands-on knowledge of FDA, ICH guidelines and Good Clinical Practices (GCP) 12) Knowledge of industry standards