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Job #02700

About our client Our client is a global leader in the production of OTC products, based in New York. The company has marketed products, 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 Senior Clinical Project Manager New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Take charge of the administration and project management of multiple Phase 1 – 4 clinical trials 2) Assist with research and protocol development as well as in-house and on-site monitoring of trials (as necessary) 3) Obtain clinical study reports 4) Oversee partnering companies on associated projects 5) Ensure adherence to Good Clinical Practice (GCP) 6) Monitor the implementation and follow-through of decisions/tasks dictated by the project, Project Team and the Manager of Clinical Operations 7) Handle development of protocol/amendment 8) Manage review of all applicable literature (SBAs, FDA guidance and other publications) in collaboration with the CRO, Data Management Group and Biostatistician 9) Handle reviewing of CRF design, modification/creation of ICF, investigator brochures, study-related forms/reports and source documents in collaboration with the CRO, Data Management Group and Biostatistician 10) Maintain financial records 11) Handle all project-related budget/finance issues Requirements 1) Bachelor’s degree in a scientific discipline (advanced degree preferred) 2) 5 – 7 years of project management experience in clinical research 3) 2+ years of experience as a Clinical Research Associate 4) In-depth knowledge of regulations as well as federal and clinical guidance 5) Demonstrated ability to work both independently and in a team environment 6) Ability to exhibit initiative 7) Ability to manage and prioritize multiple projects 8) Excellent written and verbal communication skills 9) Computer literacy (Word, Excel and PowerPoint) 10) Superb organizational skills and attention to detail 11) Willingness to travel (15% – 25%) to investigational sites, CROs, etc.