EDC Programmer

Thermo Fisher Scientific - Cambridge, MA

Full-time - Mid Level

Cambridge, MA

10,001+ employees

Computer and Electronic Product Manufacturing

About the position

The EDC Programmer at Thermo Fisher Scientific is responsible for the design, programming, compliance, and standardization of electronic data capture (EDC) databases for observational registries across various therapeutic areas. This role involves collaborating with the registry build team to transform outcome measures and adverse events into electronic case report forms (eCRFs), ensuring data integrity and adherence to regulatory standards.

Responsibilities

• Analyze CRF prototypes to recommend designs and layouts for new builds or revisions.
• Work on complex study builds requiring in-depth knowledge of the company.
• Create EDC design specifications including data dictionary, event definitions, and edit checks.
• Configure and optimize patient user interfaces for various data collection modes.
• Develop test scripts and coordinate user acceptance testing (UAT) for database accuracy.
• Manage the release of new or amended EDC databases into production.
• Maintain detailed records of eCRF changes for database amendments.
• Develop and implement EDC design standards to improve quality and streamline builds.
• Assist with mapping the EDC database to the company enterprise data warehouse.

Requirements

• Bachelor's degree preferred; high school diploma required.
• 5+ years of experience with eCRF requirements gathering, design, and specifications development.
• 2+ years of programming experience with Zelta, REDCap Cloud, or equivalent platform.
• Proven ability to lead EDC build activities for multiple projects simultaneously.
• Excellent communication skills for effective interactions.
• Advanced proficiency in Microsoft Excel or equivalent software.
• Prior experience in pharmaceutical, biotechnology, medical device, or clinical trial industries.
• Strong knowledge of FDA Title 21 CFR Part 11.
• Extreme attention to detail and ability to multitask with strong prioritization skills.

Nice-to-haves

• Experience with additional EDC platforms beyond those specified.
• Familiarity with clinical trial regulations and compliance standards.

Benefits

• Comprehensive health insurance coverage.
• 401k retirement savings plan with matching contributions.
• Paid time off and holidays.
• Professional development opportunities.
• Employee discounts on products and services.