Clinical Database Programmer

Medidata Rave EDC Study Builder / Clinical Data Programmer

📍 Location: Warszawa⏰ Employment Type: Full-time📄 Contract Type:  B2B🏢 Industry: Clinical Research / Pharma / CRO

🎯 Role Overview:

We are seeking a skilled Medidata Rave EDC Study Builder / Clinical Data Programmer to join our clinical data team. In this role, you will be responsible for developing and maintaining clinical trial databases using Medidata Rave EDC, ensuring compliance with Good Clinical Practice (GCP) and Good Documentation Practice (GDP). You will collaborate closely with Data Managers, Study Teams, Vendors, and Site Staff throughout the clinical study lifecycle.

🔧 Key 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.

✅ Required Qualifications:

• 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.

💡 Nice to Have:

• 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.

To learn more about Antal, please visit www.antal.pl