Medidata Rave QC Specialist

About the role

The QC Specialist plans, executes and documents testing activities for EDC and other clinical systems. The role ensures systems are tested and programmed to specification, supporting regulatory requirements and high-quality clinical trial data collection, and works with Data Management, Database Development and external partners to verify that system builds meet specification before study deployment.

Key responsibilities

• Lead and execute testing so systems are fit for intended use before production release.
• Develop, review and maintain test plans, test scripts, testing summaries and test data reports in line with SOPs and regulatory expectations.
• Design test scenarios for eCRFs, edit checks, integrations, data listings, data entry workflows and reporting.
• Execute tests, document results, identify defects and work with database developers to resolve them.
• Review the impact of EDC changes, amendments and mid-study updates, and support regression testing.
• Take part in risk-based testing, focusing on critical data and high-risk functionality.
• Support testing of EDC releases and system updates, including vendor release notes.
• Keep testing documentation inspection-ready for internal audits and regulatory inspections.

Required profile

• Bachelor's degree in Life Sciences, Computer Science or a related field.
• 2 years of experience in clinical systems testing within a regulated environment.
• Strong understanding of clinical trial processes, data management workflows and EDC build components.
• Working knowledge of GxP, 21 CFR Part 11 and testing lifecycle concepts.
• Experience writing and running test scripts, with strong attention to detail, analytical thinking and communication skills.

Preferred qualifications

• Experience validating other Medidata applications such as Coder, Safety Gateway and eCOA.
• Familiarity with Elluminate/CDS/CDP and risk-based testing approaches.
• Experience with in-house Sponsor Data Management models and prior involvement in regulatory inspections or audits of clinical systems.