Requirements

Operating system

Windows

Linux

Employer requirements

• Medidata Rave EDC Certified Study Builder
• OR an equivalent combination of:
• Medidata Rave Study Design and Build Essentials – Data Managers
• Medidata Rave Study Design and Build Essentials – Data Validations
• Hands-on experience building and validating Rave EDC systems in clinical trial settings.
• Familiarity with GCP, GDP, and regulatory compliance processes.
• Strong understanding of clinical data flow, SDTM mapping, and EDC best practices.
• Excellent communication skills and ability to work collaboratively in cross-functional teams.
• Experience working with SOPs and within a regulated environment.

Optional

• Experience with integration to enterprise data warehouses.
• Prior exposure to medical device studies (e.g., Boston Scientific).
• Experience with Rave Migration and Version Management tools.

Your responsibilities

• Develop, test, validate, and maintain Medidata Rave EDC clinical trial databases.
• Create EDC design specifications: data dictionary, event definitions, eConsent, edit checks, branching logic, advanced query rules, calculated fields, dynamic forms, and event rules.
• Collaborate with Data Managers and Study Teams to design and build the database using global eCRF libraries.
• Configure and optimize user interfaces for various data collection methods (eCOA, EDC).
• Develop test scripts and coordinate User Acceptance Testing (UAT) of the EDC system.
• Coordinate database go-live activities and manage production deployments.
• Perform batch data imports and support secondary data source transfers (e.g., lab or site data).
• Support internal and external audits and inspections as a subject matter expert.
• Ensure adherence to company SOPs, guidelines, and regulatory standards (GCP/GDP).
• Contribute to the development of EDC design standards to improve quality and efficiency.