Database Programmer

The eClinical / Medidata Database Programmer is responsible for building, configuring, testing, and maintaining clinical study databases and related eClinical system components. This role supports clinical trial study startup, database build, edit check programming, system configuration, user acceptance testing, issue resolution, and production support.

The ideal candidate should have hands-on experience with Medidata Rave or other eClinical platforms and should understand clinical data management processes, CRF design, edit checks, visit schedules, coding setup, external data integration, and study-specific database configuration.

Essential Functions and Responsibilities

Study Database Build and Configuration

• Build and configure study databases in Medidata Rave or other eClinical platforms based on protocol, CRF specifications, data management plan, and sponsor requirements.

• Configure electronic case report forms, visit schedules, fields, folders, matrices, forms, dynamics, derivations, and edit checks.

• Support setup of study-specific workflows, roles, permissions, user groups, sites, countries, and access controls.

• Configure standard and study-specific data entry rules, validation checks, and system behavior.

• Support setup or configuration of coding dictionaries, external data transfers, lab data, eCOA/ePRO, RTSM/IWRS, or other integrated systems as applicable.

Edit Check Programming and Validation

• Develop and maintain edit checks, derivations, dynamics, and custom functions according to approved specifications.

• Review edit check specifications and provide technical input to ensure checks are clear, accurate, and programmable.

• Perform unit testing and support independent validation of database configuration and edit checks.

• Resolve database build defects identified during testing, UAT, or production use.

• Maintain documentation of build changes, testing evidence, and issue resolution.

CRF and Specification Support

• Review clinical protocol and CRF design requirements.

• Support development or review of CRF specifications, edit check specifications, data validation specifications, and database build documentation.

• Identify inconsistencies among protocol requirements, CRFs, edit checks, and database configuration.

• Collaborate with data managers, clinical teams, programmers, vendors, and sponsors to clarify requirements.

UAT and Production Support

• Support user acceptance testing, including test script development, test execution, defect tracking, and resolution.

• Assist study teams with database-related questions during study startup, conduct, and closeout.

• Troubleshoot production database issues and implement approved changes through change control.

• Support mid-study updates, amendments, migration activities, and post-production database changes.

• Ensure all database changes are properly documented, tested, reviewed, and approved.

Quality and Compliance

• Follow applicable SOPs, work instructions, validation procedures, and study-specific requirements.

• Ensure database build activities comply with GCP, 21 CFR Part 11, audit trail expectations, and applicable regulatory requirements.

• Maintain clear documentation for system configuration, testing, validation, and change control.

• Support audits, inspections, and sponsor requests related to database build and eClinical system configuration.

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.

Preferred Qualifications

• Medidata Rave database build experience, including Architect, Designer, Coder, Custom Functions, Amendment Manager, or related modules.

• Experience with multiple therapeutic areas and global clinical trials.

• Experience supporting Phase I to Phase III studies.

• Experience with external data integration, lab data, ePRO/eCOA, RTSM/IWRS, safety systems, or central monitoring systems.

• Experience with CDISC SDTM concepts or downstream data mapping requirements.

• Experience supporting audits, database validation, or study migration activities.

• Experience working in a CRO, pharmaceutical, biotech, or clinical technology environment.

Technical Skills

• Medidata Rave or other EDC/eClinical database build tools.

• CRF design and annotation.

• Edit check programming and testing.

• Custom function development, if applicable.

• UAT test script development and execution.

• Issue tracking and change control.

• Basic understanding of clinical databases, data standards, and data flow.

• Familiarity with Microsoft Excel, Word, and project tracking tools.

• Familiarity with validation documentation and controlled system processes.

Example Deliverables

• Study database build/configuration.

• CRF specifications.

• Edit check specifications.

• Database build documentation.

• Unit testing evidence.

• UAT support documentation.

• Defect and issue resolution records.

• Change control documentation.

• Production database update documentation.

• Study database release package.

Benefits

Benefits vary by country, but remain competitive. Below is a sample of the benefits offered to U.S. employees.

• Choice of comprehensive Medical, Vision and Dental Insurance plans

• Paid vacation time and sick days

• Corporate holidays annually

• Participation in the 401K Plan

• Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc.

• Health Advocate and Employee Assistance Program

Location

This position may be remote, hybrid, or office-based.

Equal Opportunity Employer Statement

EDETEK is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Whenever possible, the company makes reasonable accommodations for qualified individuals with disabilities to the extent required by law.