The Clinical Data Manager I coordinates data management activities for investigator-initiated clinical trials from database design through delivery to Biostatistics for analysis. This role involves interpreting the study protocol and developing detailed database specifications, building forms and calendars in the current application, and ensuring appropriate structure, organization, content, and on-line instruction. The manager programs on-line logic constraints to control form behavior and prevent data entry errors, maintains data collection definitions, and documents data entry guidelines to facilitate consistency of data. Additionally, they set up data review plans, develop data edit check routines, review data for missing and incongruent data, perform patient data reconciliation between systems, and utilize a query management system to facilitate data resolution and clean-up. The manager monitors the progress of study data, assesses for analysis milestones, and releases data to the Biostatistician for analysis. They also serve as the gatekeeper for personnel access to clinical trial data and train all internal and external data entry personnel in database functionality and navigation capabilities.
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Job Type
Full-time
Career Level
Entry Level
Education Level
Bachelor's degree