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Job #02574

About our client Our client is a leading pharmaceutical company dedicated to the development and commercialization of therapeutics for unmet medical need in areas such as stroke, HIV/AIDS and obesity. With strong financial backing, an experienced management team, and an 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 Study Manager New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Act as a primary interface between the company and the responsible CRO(s) involved in the operations of clinical trials 2) Assist in the preparation of writing study protocols 3) Interact with principal and co-investigators and other site staff, managing study documentation i.e., The Trial Master File, and supervision of CRAs in the field 4) Lead and manage to ensure proper operational execution of assigned clinical trial(s), including selection and oversight of CROs/vendors/investigators 5) Develop, review and archive project specific core documents 6) Prepare and manage project timelines 7) Ensure coordination of critical time dependent variables 8) Manage one or more clinical trials within a specific therapeutic area 9) Ensure that clinical trials are conducted in compliance with FDA regulations and guidance, ICH and other relevant local and international GCP guidance and CRO SOPs 10) Mentor, supervise and provide ongoing training to one or more CRAs or clinical study assistants 11) Ensure that monitoring/co-monitoring visit reports and CRO monitoring visit reports are being reviewed and followed 12) Coordinate all aspects of assigned clinical activities, including managing CROs, vendors, timelines and tracking of CRO/consultant deliverables 13) Develop and maintain in conjunction with the Project Leader, detailed project timelines for assigned clinical trials 14) Identify risks and develop contingency plans to reduce the impact of risks 15) Communicate accurately in a comprehensively written and verbal manner concerning to the clinical trials within timelines 16) Provide the study management with components of protocol budget, including country monitoring agreements, investigator grants, lab costs, FSP/CRO costs, clinical supplies and investigator meeting costs 17) Assist the Clinical Leader in leading cross-functional team meetings to review clinical trial timelines, objectives, deliverables, quality issues and other day-to-day operations 18) Ensure internal and external meeting minutes and agendas are generated and disseminated (as appropriate) 19) Maintain the Trial Master File 20) Ensure that recruitment plans are in place and are executed in a timely manner in order to enhance the study enrollment to meet corporate goals Requirements 1) B.A./B.S., M.S. preferred 2) Minimum 5 years of experience in pharmaceutical clinical research 3) Hands-on experience with Electronic Data Capture (EDC) and Interactive Voice Recognition Systems (IVRS) 4) Experience in obesity, hematology or dermatology preferred 5) Experience of Clinical Trial Methodology (study and design) 6) Excellent understanding of traditional CRA skills (site identification, monitoring, tracking, data collection and cleaning) and clinical study management 7) Working knowledge of FDA regulations, ICH and GCP guidelines 8) Excellent organizational and planning skills