Senior RAVE Clinical Database Programmer

Katalyst-Healthcares-; Port Reading (NJ); Presencial; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

Creative Solutions Services, LLC in New Jersey seeks a Senior RAVE Clinical Database Programmer to design, develop, validate, and maintain clinical study databases, partnering with Clinical Data Management and cross-functional teams to support successful trial execution.

The role leads database programming across studies, reviews CRF specs, builds CRF screens, programs edit checks and derivations, plans UAT, and coordinates study migrations to ensure high-quality, compliant deliverables.

Formación

• Experience with Medidata Rave and CDMS environments.
• Ability to translate study requirements into CRF designs.
• Experience coordinating UAT and validation documentation.

Responsabilidades

• Lead study database design within the CDMS across multiple studies.
• Review CRF Specifications and Data Validation Specifications (DVS).
• Build CRF screens based on approved CRF Specifications.
• Program edit checks, special actions, and derivations per DVS.
• Plan and coordinate edit check test script development, validation, and UAT.
• Lead and support database migration activities and updates.
• Coordinate with cross-functional teams to align with study timelines.
• Troubleshoot study build and system integrations and changes.
• Develop advanced custom programs as required by study specs.

Conocimientos

Medidata Rave

CRF design

CDMS programming

Data validation

Cross-functional collab

Herramientas

SQL

Descripción del empleo

Job Description:
The Senior RAVE Clinical Database Programmer participates in the design, development, validation, and maintenance of clinical study databases. This individual applies advanced knowledge of CRF design, database configuration, edit check programming, custom programming, reporting, system integrations, and CDMS functionality while partnering closely with Clinical Data Management and cross-functional study teams to support successful clinical trial execution.

Key Responsibilities:

• Serve as the primary owner of study-specific database design within the CDMS (e.g., Medidata Rave; experience preferred), leading clinical database programming activities across multiple studies of complex design.
• Review database specification documents created by study teams, including CRF Specifications and Data Validation Specifications (DVS).
• Build clinical study database CRF screens based on approved CRF Specifications.
• Program edit checks, special actions/functions, custom programs, and derivations in accordance with the DVS.
• Plan and coordinate edit check test script development, programming, validation, and User Acceptance Testing (UAT) activities. Ensure issues are resolved in a timely manner and produce validation documentation for study teams and the Trial Master File (TMF).
• Complete study database updates in accordance with Change Request documentation and procedures, including performing impact analyses and risk assessments for proposed changes.
• Lead and support database migration activities, including live study updates and database maintenance.
• Partner with Clinical Data Management, Clinical Operations, Biostatistics, and external vendors to coordinate clinical database programming activities and ensure alignment with study timelines and objectives.
• Participate in project meetings, contribute to problem-solving discussions, communicate project risks, and proactively elevate issues that may impact timelines, scope, or quality.
• Balance multiple study assignments while effectively managing priorities and communicating resource needs.
• Troubleshoot and resolve study build, system integration (e.g., IVRS, CTMS), and change request issues using the appropriate applications.
• Develop advanced custom programs and functionality as required by study specifications.
• Ensure high-quality deliverables by reviewing study-level, program-level, and multi-study core deliverables for accuracy, completeness, and compliance.
• Participate in departmental initiatives, user group meetings, and knowledge-sharing activities to promote best practices and awareness of new system features.
• Develop detailed study execution plans, including programming, testing, and UAT milestones, providing clear visibility into study startup progress and key deliverables.
• Support the ongoing evolution of internal EDC capabilities by serving as a technical resource to cross-functional study teams and helping establish efficient database programming processes.