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Job #02571

About our client Our client is a rapidly growing medical device company headquartered in San Diego that is known for innovative strides in the development and commercialization of minimally invasive therapies. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Clinical Manager San Diego, CA Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the management of the clinical research function 2) Lead/guide the Clinical Project Team in study start-up and ongoing clinical management and monitoring activities 3) Establish and implement study protocols, case report forms, informed consents and other study documents 4) Oversee clinical research site enrollment and general project-related performance 5) Prepare and manage IRB submissions and related communications 6) Manage adherence to study timelines 7) Provide overviews on day-to-day activities to the project-specific Operational Team for study start-up and initiation, monitoring and study closure 8) Establish and implement corporate procedures for the planning and execution of clinical trials 9) Assist in creating and managing site budgets 10) Conduct site qualification and/or initiation visits and train site personnel when necessary 11) Recruit patients, including screening evaluations, to determine subject eligibility 12) Conduct site monitoring visits acting as primary site liaison 13) Ensure site and clinical compliance with applicable regulatory requirements 14) Track patient enrollment and withdrawal 15) Interact and provide guidance for study participants, including study visit adherence 16) Develop tools for training and support of sites and CRAs 17) Facilitate efficient, accurate and compliant clinical research 18) Provide training and supervision to CRAs as well as other individuals involved in the study Requirements 1) B.S. in Life Science, Biological Science or equivalent 2) Minimum 1 year of experience as a Clinical Trial Manager 3) 3+ years of experience as a CRA 4) Experience in managing CRAs 5) Minimum 5 years of experience in a healthcare-related field or industry in a clinical setting 6) Experience in medical devices 7) Excellent understanding of traditional CRA skills – site identification, monitoring, tracking, data collection and cleaning – and clinical study management 8) Extreme understanding of current regulatory requirements (GCP/ICH/FDA) 9) Excellent computer skills, particularly with database applications (preferred) 10) Superb communication skills (written and oral)