EDC Programmer

6 days ago

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• Design, program, and standardize EDC database builds for observational registries. • Coordinate with registry build team for developing electronic case report forms. • Analyze CRF prototypes and recommend designs for database builds. • Create specifications including data dictionary, event definitions, and conditional logic. • Develop and optimize patient user interfaces for data collection. • Conduct user acceptance testing to ensure database accuracy. • Manage release of new or amended EDC databases into production. • Maintain records of changes for database amendments. • Implement design standards to improve quality and streamline builds. • Assist with mapping EDC to enterprise data warehouse.

Requirements

• 5 or more years' experience with eCRF requirements gathering, design, and specifications development. • 2 or more years' programming experience with Zelta, REDCap Cloud, REDCap, or equivalent platform. • Proven ability to lead EDC build activities for large, multiple projects simultaneously. • Ability to maintain confidentiality of data and information during interactions with staff at all levels. • Excellent communication skills to support effective interactions. • Advanced proficiency in Microsoft Excel or equivalent software. • Prior experience in the pharmaceutical, biotechnology, medical device/diagnostic, or clinical trial industries. • Strong knowledge of FDA Title 21 CFR Part 11. • Extreme attention to detail and ability to multitask with strong prioritization, planning, and organization skills. • Dedication to process improvement while producing high quality work within required timeframes. • Strong English communication and writing skills.