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Job #02758

About our client Our client is a rapidly growing biotech company headquartered in Maryland that is focused on the development and commercialization of various therapeutics for infectious diseases. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Clinical Project Manager Rockville, Maryland Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee operational aspects of vaccine clinical trials, including creation of operation plans with tracking as well as management of deliverables and risk mitigation 2) Liaise with CROs and study sites in implementing vaccine clinical trials 3) Assist the scientific staff in developing protocols and other scientific documents 4) Lead Clinical Trial Team meetings to communicate project goals and identify tasks 5) Assign tasks/due-dates to the Clinical Trials Team and follow-up progress to manage trials toward established goals and target dates 6) Identify, evaluate, select and develop contracts for external vendors (CROs) to implement vaccine clinical trials 7) Oversee plans related to site-monitoring, adverse event reporting/monitoring, worksheet development, data handling and entry guidelines as well as data management 8) Identify and track key study metrics 9) Develop and track study budgets 10) Identify/anticipate issues (early) and conduct root-cause investigations for issue resolution and/or escalation (as needed) 11) Coordinate distribution and re-supply of vaccine and other clinical supplies 12) Assist with developing and reviewing scientific documents, including protocols, investigator brochures and generic consent forms 13) Prepare and review Statements of Work and Requests for Proposals 14) Develop and update SOPs and study-specific procedures, pertaining to management of clinical studies (according to GCPs) 15) Select and manage sites conducting vaccine clinical trials 16) Educate sites, assist with IRB submissions as well as answer protocol- and patient-related questions 17) Assist with patient recruitment plans and monitor site performance 18) Facilitate the maintenance of regulatory documents and supporting sites during audits/inspections 19) Remain current on scientific and regulatory developments in the vaccine industry as well as clinical trial implementation 20) Manage additional clinical research managers (when needed) Requirements 1) Bachelor’s degree in a scientific discipline (RN, MS, or Ph. D. a plus) 2) Minimum 5 years of experience in clinical research operations and/or clinical project management (Phases 1 through3) in a CRO, pharmaceutical or biotechnology environment 3) Experience in clinical operations, clinical development and/or clinical project management 4) In-depth knowledge of ICH GCP guidelines and FDA (CBER) requirements for vaccine clinical trials 5) Excellent computer skills (MS Word, Excel, Power Point, MS Project) to track and manage projects, and facilitate communication 6) Superb interpersonal and communication skills 7) Exceptional negotiation and problem-solving skills 8) Strong leadership and management skills 9) Excellent communication (verbal and written) skills