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Database Programmer

20 hours, 1 minute ago
Argentina, Brazil, United States
Full-time
Mid Level
Database Administrator
Software Development
GCP
Apply Now
EDETEK

EDETEK

EDETEK Inc. is a premier provider of digital clinical trial systems, offering innovative solutions to streamline data collection and analysis for pharmaceutical and biotech companies.

Internet Software & Services
51-250
Founded 2009
View All Jobs 9

Description

  • Build and configure study databases in Medidata Rave or other eClinical platforms based on protocol, CRF specifications, data management plans, and sponsor requirements.
  • Configure eCRFs, visit schedules, fields, folders, matrices, forms, derivations, dynamics, and edit checks.
  • Set up study workflows, roles, permissions, user groups, site and country access, and related system controls.
  • Configure data entry rules, validation checks, coding dictionaries, and integrated systems such as external data transfers, lab data, eCOA/ePRO, and RTSM/IWRS.
  • Develop, maintain, and validate edit checks, derivations, custom functions, and other database logic.
  • Review specifications and collaborate with data managers, clinical teams, programmers, vendors, and sponsors to clarify requirements and resolve inconsistencies.
  • Support unit testing, user acceptance testing, defect tracking, and validation of database build changes.
  • Troubleshoot production database issues and implement approved changes through change control.
  • Support study startup, amendments, migrations, mid-study updates, and closeout activities.
  • Maintain documentation for build changes, testing evidence, issue resolution, and change control, and support audits and inspections.

Requirements

  • Bachelor’s degree in life sciences, computer science, information systems, statistics, data management, or a related field.
  • Hands-on experience building clinical study databases in Medidata Rave, Rave EDC, or similar eClinical systems.
  • Experience with CRF design, edit check programming, database testing, and UAT support.
  • Good understanding of clinical trial processes and clinical data management activities.
  • Familiarity with GCP, 21 CFR Part 11, and computerized system validation principles.
  • Strong attention to detail and ability to follow specifications and controlled processes.
  • Good communication skills and ability to work with data management, clinical operations, programming, QA, vendors, and sponsor teams.
  • Medidata Rave database build experience, including Architect, Designer, Coder, Custom Functions, Amendment Manager, or related modules (preferred).
  • Experience with multiple therapeutic areas, global clinical trials, and Phase I to Phase III studies (preferred).
  • Experience with external data integration, lab data, ePRO/eCOA, RTSM/IWRS, safety systems, central monitoring systems, CDISC SDTM concepts, audits, validation, or study migrations (preferred).

Benefits

  • Choice of comprehensive medical, vision, and dental insurance plans.
  • Paid vacation time and sick days.
  • Corporate holidays annually.
  • Participation in a 401(k) plan.
  • Perks and discount programs covering AAA, wholesale, insurance, Rx, fitness, pets, entertainment, and more.
  • Health Advocate and Employee Assistance Program.
  • Remote, hybrid, or office-based work options.
  • Benefits vary by country, with competitive U.S. employee offerings.

Interested in this position?

Apply directly on the company website

Apply Now

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