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Job #03141

About our client Our client is the biotech division of a world-leading healthcare company that has developed a reputation for successfully bringing complex products to market in a variety of therapeutic areas. With an experienced clinical team and empowering corporate culture that is focused on the professional development of its employees, this is a great opportunity for the right candidate. Position Location Clinical Compliance and Training Manager Southern California Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage and conduct training activities supported by Clinical Compliance and Training including training of Clinical and Medical Affairs personnel, study teams and investigative sites on applicable clinical regulatory requirements including ICH-GCP, EU Directive and FDA requirements 2) Perform GCP audits of investigative sites and external service providers and internal reviews in support of clinical studies sponsored and/or managed by the company's Clinical Research and Development Department 3) Manage the designing, development, organization and delivery of ICH-GCP and SOP training sessions/program for Clinical Research and Development teams 4) Organize, conduct and oversee documentation of internal training sessions for all US team members involved in clinical research and development 5) Provide on-going training regarding regulatory compliance 6) Conduct research and communicate (proactively) local and international GCP trends and initiatives to ensure compliance 7) Provide guidance on interpreting and applying existing and new regulatory requirements 8) Oversee development and ongoing maintenance of annual training plans and records 9) Manage development and maintenance of training information resources 10) Design, develop and manage Clinical R&D new hires’ on-boarding training program 11) Participate in developing and training new staff 12) Interface, as required, with cross-divisional clinical training groups audits and compliance assessments 13) Plan, schedule and conduct GCP audits (routine and directed) of investigative sites and/or external service providers 14) Coordinate audit follow up and corrective actions 15) Communicate specific GCP or related compliance issues to management and assist in resolving compliance issues 16) Conduct pre-inspection support activities prior to investigative site inspections 17) Provide Corporate Compliance Services with auditing support (as required) Requirements 1) 4+ years of experience in the field of industry-sponsored clinical research and development including training experience in clinical research 2) 1 year of GCP/QA auditing experience 3) Excellent knowledge of ICH-GCP requirements 4) Demonstrated ability to communicate complex concepts clearly and succinctly 5) Excellent verbal and written communication skills 6) Ability to prioritize work, manage multiple projects and maintain quality simultaneously 7) Ability to function independently 8) Ability to mentor colleagues and junior-level team members 9) Team-oriented with excellent interpersonal skills 10) Proficiency in MS Office suite 11) Willingness and ability to travel