Location/Division Specific Information
#CorEvitas
Discover Impactful Work:
As part of the Clinical Data Management (CDM) team, the EDC (Electronic Data Capture) Programmer is responsible for the design, programming, compliance, and standardization of new and amended EDC database builds for multiple observational registries in a variety of therapeutic areas. The individual works closely with registry build team to coordinate the transformation and development of select outcome measures, adverse events of interest, and other data elements into electronic case report forms (eCRFs). Experience designing and/or programming in industry recognized EDC platform, required; Zelta is preferred.
A day in the Life:
• Zelta is preferred.
ESSENTIAL FUNCTIONS
• Analyze the content of CRF prototypes to determine and recommend designs and layouts for new builds or revisions to an existing database.
• Work on complex study builds where an analysis of database requirements calls for an in-depth knowledge of the company.
• Create EDC design specifications that include the data dictionary, event definitions, electronic consent, branching logic, edit checks, advanced query rules, calculated fields, and dynamic form and event rules.
• Configure and optimize multiple patient user interfaces to support different modes of data collection (mobile device or tablet, laptop/desktop computer)
• Develop test scripts and coordinate EDC user acceptance testing (UAT) to ensure accuracy of database structure, content, and validation controls based on the original specifications.
• Coordinate and manage the release of new or amended EDC databases into production.
• Maintain a detailed record of eCRF changes for each database amendment.
• Develop and implement EDC design standards to improve quality and streamline database build efforts.
• Assist with mapping the EDC database to the company enterprise data warehouse.
Keys to Success:
Education
• Bachelor's degree preferred, High school diploma required
Experience
• 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.
Knowledge, Skills, Abilities
• 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.
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