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Job #02869

About our client Our client is a rapidly growing biotech company headquartered in Northern California that is focused on the development and commercialization of various therapeutics for inflammation and disorders of the nervous system. The company has an experienced management team, multiple programs and an empowering corporate culture that is focused on the professional development of its employees. Position Location Clinical Data Manager Seattle, Washington Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee clinical data management activities for the entire life cycle of clinical studies 2) Ensure complete, accurate and consistent clinical data output 3) Oversee data management activities performed by external vendors 4) Establish and build electronic clinical database utilizing standardized computer database system 5) Implement clinical data management tasks like CRFs, development, annotations, modifications, etc. 6) Lead preparation and delivery of standard clinical data management documents (data management plans, data validation plans, etc.) 7) Ensure that documents adhere to regulatory guidelines 8) Review data for integrity and cleanliness during study conduct 9) Coordinate processes of database cleaning, QC and lock 10) Perform supervisory tasks as per organization’s policies and applicable laws 11) Interview, hire and train employees 12) Plan, assign and direct work 13) Appraise performance as well as reward and discipline employees 14) Address complaints and resolve problems Requirements 1) BS 2) Minimum 3 years of experience in clinical drug development within the pharmaceutical/biotech industry along with a proven track record 3) In-depth understanding of clinical data management processes and policies 4) Knowledge of GCP and FDA regulatory requirements 5) Experience in effectively prioritizing and managing multiple tasks simultaneously 6) Proficiency in computers with experience in clinical data management systems (CDMS) and SAS programming 7) Ability to work independently 8) Ability to build and maintain positive relationships with the management, peers and subordinates 9) Excellent organizational and interpersonal skills 10) Personal integrity with keen attention to detail 11) Superb analytical and problem-solving skills 12) Excellent communication skills (written and verbal) 13) Ability to engage in intermittent physical activity (bending, reaching, pushing, pulling or lifting up to 40 lbs) with occasionally prolonged periods of sitting