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.