Rave EDC QA & Validation Specialist

Cytel; Colombia; On-site; COP 60,000,000 - 90,000,000; Full time

Job summary

Cytel is seeking a QC Specialist to plan, execute, and document testing activities for EDC and related systems. You will ensure systems meet specifications and regulatory requirements, collaborating with Data Management and external partners to verify builds before study deployment.

The role emphasizes risk-based testing, test script development, and inspection-ready documentation to support audits and regulatory inspections. Strong knowledge of GxP and 21 CFR Part 11 is preferred.

Qualifications

• Bachelor’s degree required in Life Sciences, Computer Science, or related field.
• 2 years of clinical systems testing in a regulated environment.
• Hands-on with Medidata Rave EDC.
• Knowledge of GxP, 21 CFR Part 11, and testing lifecycles.
• Experience writing and executing test scripts.
• Strong attention to detail and communication skills.

Responsibilities

• Lead and execute testing activities ensuring systems are tested and fit for intended use prior to production release.
• Develop, review, and maintain test documentation, including test plans, test scripts, testing summary, and test data reports in accordance with SOPs and regulatory expectations.
• Design test scenarios to validate eCRF functionality, edit checks, integrations, data listings, data entry workflows, and reporting functionality.
• Execute testing, document results, identify defects, and collaborate with database developers to resolve issues.
• Review and assess the impact of EDC changes, amendments, and mid-study updates on testing status; support regression testing as required.
• Participate in risk-based testing activities, focusing testing efforts on critical data and high-risk functionality.
• Support testing of EDC releases and system updates, including assessment of vendor release notes and impact to existing studies.
• Ensure testing documentation is inspection-ready and supports internal audits and regulatory inspections.

Skills

Clinical systems testing

Regulatory compliance

Documentation & reporting

Analytical thinking

Education

Bachelor’s degree in Life Sciences, Computer Science, or related field

Tools

Medidata Rave EDC

Job description

Cytel is seeking a QC Specialist to plan, execute, and document testing activities for EDC and related systems. You will ensure systems meet specifications and regulatory requirements, collaborating with Data Management and external partners to verify builds before study deployment.

The role emphasizes risk-based testing, test script development, and inspection-ready documentation to support audits and regulatory inspections. Strong knowledge of GxP and 21 CFR Part 11 is preferred.