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Job #03478

About our client Our client is a not-for-profit, product development partnership accelerating the discovery and development of new tuberculosis (TB) drugs. The company has a diverse donor base comprising of private foundations and enterprises, governments, multilateral donors, and individuals, and since 2000 they have received more than $250 million in financial contributions. They have an experienced management team and are focused on the long-term professional development of their employees Position Location Clinical Operations Manager New York, NY Salary Highly competitive package, commensurate with experience Responsibilities 1) Building and maintaining excellent rapport and interacting effectively and comfortably with outside experts, partners, and regulatory agencies. Acting as a representative and spokesperson to the public when called upon to do so 2) Managing and overseeing CROs and other partners participating in clinical trials, including investigational sites, to ensure successful conduct and completion of the trials and their associated study reports 3) Defining, together with the Head of Clinical Development and Head of Project Management, project targets and time tables and assessing resource requirements, both personnel and financial, to ensure feasibility of clinical development plans 4) Evaluating progress of each trial to ensure that resources are being put to their best use and that the project will meet all critical success factors; preparing materials for interim and formal project reviews 5) Staying current on developments in TB treatment R&D in industry and academia Requirements 1) Minimum of Bachelor's degree in scientific discipline 2) 5+ years of industry or CRO experience monitoring and managing complex clinical trials 3) A good grasp of regulatory requirements, current good clinical practices (cGCP/cGLP), and clinical drug development. Proven ability to work well and effectively in a team environment 4) Infectious disease and/or respiratory disease clinical trial experience preferred 5) A hands-on approach to overseeing clinical trials coupled with a willingness and ability to travel to clinical trial sites, depending on program needs