Clinical Data Manager II – QC Specialist
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Job Description
Clinical Data Manager II testing Medidata Rave EDC and clinical systems. Ensuring compliant, inspection-ready builds for high-quality clinical trial data collection.
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
Requirements:
- Bachelor’s degree in Life Sciences, Computer Science, or a related field
- 2 years experience in clinical systems testing within a regulated environment
- Hands-on experience with Medidata Rave EDC
- Strong understanding of clinical trial processes, data management workflows, and EDC build components
- Working knowledge of GxP regulations, 21 CFR Part 11, and testing lifecycle concepts
- Experience authoring and executing test scripts
- Strong attention to detail, analytical thinking, and problem-solving skills
- Excellent written and verbal communication skills
- Preferred: Experience validating other Medidata applications (e.g., Coder, Safety Gateway, eCOA)
- Preferred: Familiarity with Elluminate/CDS/CDP
- Preferred: Familiarity with risk-based testing approaches
- Preferred: Experience working with in-house Sponsor Data Management models
- Preferred: Prior involvement in regulatory inspections or audits related to clinical systems
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