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Sr Clinical Study Manager

Aliso Viejo, CA

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Clinical Study Manager is responsible for the oversight and management of Avanir clinical studies, including coordination with other relevant parties (e.g., other Avanir departments, contract vendors, etc.). Responsibilities include the planning, execution and completion of clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and Avanir SOPs, within agreed-upon timeframes and budget. Essential Job Functions: Provides oversight and project management of clinical studies at Avanir, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Avanir SOPs. Manage and facilitate development/review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents (e.g. Study Plans, Case Report Forms, Source Documents, Monitoring Plans, Data Management Plan, Project Management Plan, etc.) Provide clinical operations oversight in the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites. Supervise clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Avanir SOPs.u00a0 Manage, coordinate, and provide ongoing assessment, evaluation, and communication with other Avanir departments (e.g., Regulatory, Drug Safety, and Clinical Trial Materials) and external vendors (CRO, consultants, etc.) to ensure study objectives/timelines are accomplished. Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required. Participate in forecasting study expenditures and resourcing needs. Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast. Provide timely communication of any variances in budget forecast to the Clinical Department Head. Establish communication flow with CRO and investigative sites to maximize compliance with study protocol. Manage recruitment efforts and activities to meet study enrollment goals and timelines. Minimum Qualifications: Minimum BA/BS in life sciences or equivalent college program, and/or commensurate experience in the clinical research industry; Masteru2019s Degree preferred 10 years of experience in the pharmaceutical/biotechnology industry 3 years demonstrated work experience of successfully managing clinical trials within the pharmaceutical industry, including CRO and contract vendor management, preferably in the CNS therapeutic area. Experience in management of international or global clinical trials is preferred Strong project management skills Experience in clinical site monitoring is preferred Experience in development of essential clinical study documents, including informed consent, monitoring plans, source documents, Case Report Forms (CRFs), study recruitment plans, etc. Experience in protocol development/writing is preferred Both working and theoretical knowledge of ICH GCP, clinical trials management with exposure to various phases of drug/trial development life cycle preferred (e.g., Phase I- IV, start-up through close-out), scientific methods, research design, regulatory compliance, and clinical data management. Demonstrated strengths in planning, organizational, analytical skills, oral and written communication, time management, conflict management, problem solving, and attention to detail. Ability to supervise, direct and lead team members as well as interact with other internal staff. Strong planning and organizational skills with ability to multi-task and plan activities as they relate to the management of clinical trials, ability to problem-solve. Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with physicians, outside vendors, consultants, and team members. Possess advanced computer skills (Microsoft applications, spreadsheets, etc.) Ability to work effectively within a team matrix as well as independently. Financial management skills as applicable to oversee project expenditures. Ability to travel up to 25% travel including ground and air required

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