Clinical Database Programmer - Remote

Job Description

Job Description

The Clinical Database Programmer is responsible for the hands-on design, build, testing, deployment, and ongoing maintenance of clinical trial databases within Medidata Rave. This individual will support studies throughout the database lifecycle, from protocol review and initial database development through production maintenance, amendments, data cleaning, and database lock.

The ideal candidate will have extensive hands-on Medidata Rave programming experience and the ability to independently build and maintain clinical databases while supporting traditional clinical data management activities. This role requires a strong understanding of clinical data collection, database design, edit checks, data quality, external data integrations, and downstream data requirements.

Responsibilities

• Design, build, program, test, deploy, and maintain clinical trial databases in Medidata Rave in accordance with study requirements and industry standards.
• Translate protocols and data collection requirements into effective eCRF and database designs.
• Lead eCRF design and review meetings with Data Management and cross-functional study teams.
• Develop and maintain eCRFs, edit checks, validations, derivations, forms, fields, folders, dictionaries, and other Rave database components.
• Perform post-production database maintenance, including amendments, configuration changes, edit check updates, troubleshooting, and other study lifecycle modifications.
• Assess database changes and perform required programming, testing, documentation, deployment, and post-production verification.
• Develop, execute, and document database testing and UAT for initial builds and subsequent amendments.
• Review and maintain validation/edit checks for internally managed and outsourced studies.
• Perform clinical data management activities including data review, query management, discrepancy resolution, data cleaning, reconciliation, and database freeze/lock preparation.
• Monitor production databases and resolve database, data entry, edit check, and data quality issues.
• Provide technical expertise and ongoing database support to Clinical Data Management.
• Collaborate with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety, CROs, and external vendors.
• Support development and maintenance of external data transfer specifications and retrieve, load, review, and reconcile external/vendor data.
• Develop, test, and maintain data review listings/tools using JReview, SAS, and/or other applicable technologies.
• Perform post-processing of clinical data extracts for delivery to Biostatistics and Statistical Programming.
• Ensure database design supports CDISC/CDASH requirements and downstream SDTM programming.
• Support user access, roles, permissions, and study-level database configuration.
• Manage multiple study priorities and timelines while ensuring accurate, timely deliverables.
• Develop and maintain appropriate database and Data Management documentation.
• Follow applicable SOPs, FDA/ICH guidelines, GCP, GCDMP, and industry standards.

Requirements

• Master’s degree in Computer Science, Life Sciences, Health Sciences, Mathematics, Statistics, or related scientific/technical discipline.
• Minimum 5 years of clinical database programming and/or clinical data management experience within pharmaceutical, biotechnology, or clinical research.
• Advanced hands-on Medidata Rave database programming and build experience required.
• Demonstrated ability to independently design, build, program, test, deploy, and maintain Medidata Rave databases.
• Strong experience with eCRF design, database configuration, edit check programming, validation/UAT, amendments, and production maintenance.
• Experience supporting databases through the complete study lifecycle, including post-build maintenance through database freeze and lock.
• Hands-on knowledge of clinical data management activities including data cleaning, query management, discrepancy resolution, reconciliation, and database lock.
• Knowledge of clinical database/CRF design, data validation, central laboratory data, and external/vendor data.
• Strong understanding of clinical trial design and cross-functional relationships among Data Management, Biostatistics, Statistical Programming, and Clinical Operations.
• Knowledge of FDA/ICH guidelines, GCP, GCDMP, and applicable industry standards.
• Knowledge of SQL and clinical data extracts/data transfer processes.
• Strong analytical, troubleshooting, organizational, communication, and problem-solving skills.
• Ability to independently manage competing priorities and timelines with strong attention to detail.