Job DescriptionPrimary Function of the Position The candidate will manage design, develop, implement, validate, maintain, and support clinical databases related to pre-market or post-market clinical studies/registries. The candidate will have an understanding of data design, development, and implementation processes to develop EDC systems. The candidate will be responsible for adhering to the required departmental operating procedures regarding Data Management for clinical investigations.
Essential Job Duties Develop project-specific data management plans that include design, creation, and lifecycle management of data collection, validation, reporting specifications, and usage guidelines.Understand CRF design and interpret protocol requirements for efficient EDC design.Create clinical database design specifications, including edit check specifications.Experience with validation of EDCs at a study level, including experience developing study requirements, test scripts, and UAT documentation.Administration of existing EDC systems for multiple studies simultaneously.Provide clinical data management support for study operations and analysis groups, including:Assisting in defining and creating data listings, including programming software to generate listings.Data specifications and/or processing data transfers in preparation for statistical review.Training users on EDC systems, including creating training documentation and running training sessions for end users.Data cleaning and review of clinical data, including query management and data listing review.Manage post-go live issues and requests.Manage activities for multiple studies simultaneously in a dynamic environment.Contribute to the development and/or maintenance of departmental operating procedures for data management.Proactive in understanding company needs/priorities and able to autonomously seek solutions. Work on significant and unique issues in critical situations and provide solutions proactively.
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