Job Description
The QC Specialist is responsible for planning, executing, and documenting Testing activities for EDC and other systems. This role ensures that systems are tested and programmed to specification, supporting regulatory requirements and high-quality clinical trial data collection. The QC Specialist works closely with Data Management, Database Development, and external partners to verify that system builds meet specification expectations prior to study deployment. and programmed to specification, supporting regulatory requirements and high-quality clinical trial data collection, and external partners to verify that system builds meet specification expectations prior to study deployment.
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. 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.
Qualifications
Required Qualifications
- Bachelor's degree in Life Sciences, Computer Science, or a related field.
- 2 years experience in clinical systems testing within a regulated environment 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 Qualifications
- Experience validating other Medidata applications (e.g., Coder, Safety Gateway, eCOA).
- Familiarity with Elluminate/CDS/CDP.
- Familiarity with risk-based testing approaches.
- Experience working with in-house Sponsor Data Management models.
- Prior involvement in regulatory inspections or audits related to clinical systems.
