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Job #03015

About our client Our client is focused on applying its proprietary technologies to develop innovative drugs for neurological diseases and targeted therapeutics to prevent neurological degenerative disorders. This is a great opportunity for the right candidate! Position Location Senior Clinical Project Manager North Carolina Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the administration and project management of multiple Phase I - IV 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) Handle development of protocol/amendment 7) Manage reviewing of all applicable literature (SBAs, FDA guidance and other publications) in collaboration with the CRO, Data Management Group and Biostatistician 8) Handle reviewing of CRF design, modification/creation of ICF, investigator brochures, study-related forms/reports and source documents 9) Hire, train and manage staff in India office 10) Handle all project-related budget/finance issues 11) Interact with CROs regularly 12) Ensure adequacy of clinical research staff/facilities with respect to protocol and regulatory requirements 13) Develop, implement and manage monitoring plans 14) Obtain and provide study update information Requirements 1) Bachelor’s degree in a scientific discipline (advanced degree preferred) 2) Minimum 4 years of project management experience in clinical research 3) 3+ years of experience as a Clinical Research Associate 4) Previous experience managing and supervising staff in India 5) In-depth knowledge of regulations as well as federal and clinical guidance 6) Excellent communication skills (written and verbal) 7) Ability to manage and prioritize multiple projects 8) Computer literacy (Word, Excel and PowerPoint) 9) Superb organizational skills and attention to detail 10) Willingness to travel internationally (up to 30%) to investigational sites, CROs, etc.