Must meet all requirements for Principal Clinical Research Associate position and have demonstrated proficiency in all relevant areas. Provides guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines. Responsible for development and monitoring of study budgets and timelines. Partners with functional peers to manage, adjust, and revise project timelines/budgets as necessary. Develops RFPs, select CROs/vendors, and manages external resources. Communicates project status and issues and ensure project team goals are met. Participates in development of SOPs, Clinical Study Reports, INDs, NDAs, and other clinical, regulatory, safety documents. Contributes to development of abstracts, presentations, and manuscripts. Recruit, hire, mentor, and manage CPA/CRA direct reports and support their professional development. Participate in training of CPAs and Crass. Successfully develops, implements, and completes clinical trials. Manages designated program budget and timelines. May determine activities critical to company success and priorities within functional area. Anticipates moderately complex obstacles and client difficulties and implements solutions to achieve project goals. May design and use all available vehicles for scientific communication within company. With limited supervision may participate in or lead departmental strategic initiatives. Travel is required.
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