EDC Programmer

Job Summary

Rave Certified EDC Programmermust have strong hands-on experience in Phase III clinical trials in Oncology to design, build, validate, and maintain EDC databases in line with study protocols, SOPs, and regulatory standards. The role will collaborate closely with CDM, Biostatistics, and Clinical Operations to ensure high-quality, compliant clinical data collection.

Key Responsibilities

• Design, build, and maintain EDC databases using Medidata Rave(Rave Builder)
• Develop eCRFs, visit schedules, edit checks, derivations, and user roles
• Lead Phase III study builds, UAT, and go-live support
• Implement protocol amendments and mid-study database updates
• Ensure EDC configuration complies with SOPs, GCP, and 21 CFR Part 11
• Support data cleaning by resolving EDC-related technical issues
• Prepare and maintain build documentation, validation evidence, and change control
• Collaborate with CDM to translate protocol and CRF requirements into functional EDC design
• Provide technical support to clinical sites and internal teams

Required Skills & Experience

• 8+ years of hands-on EDC programming experience
• 5+ experience supporting Phase III clinical trials in Oncology is required
• Medidata Rave Certification (mandatory)
• Strong expertise in Rave Builder, edit checks, derivations, and UAT
• Good understanding of CDISC concepts (SDTM basics)
• Solid understanding of clinical trial lifecycle and data management processes
• Familiarity with regulatory compliance (GCP, 21 CFR Part 11)
• Good communication and documentation skills

Preferred / Nice to Have

• Experience with global, multi-country trials
• Exposure to other EDC tools such as Oracle Oracle Clinicalor VeevaVault CDMS
• Experience with integrations (labs, eCOA, IVRS/IWRS)
• CRO / Sponsor-side experience

Education

• Bachelors degree in Life Sciences, Pharmacy, Biotechnology, Computer Science, or related field