
Clinical Data SME Tester
4 weeks ago
Key Responsibilities:
- Bachelor's degree in Life Sciences, Computer Science, or related field.
- 8+ years of experience in clinical data testing and validation.
- Perform UAT for CRF screens, database edit checks, and exceptional reports/listings.
- Test clinical study setup configurations including protocol parameters, visit schedules, and form designs.
- Validate external data acquisition (Lab, ECG, PK/PD) and ensure accurate processing.
- Collaborate with Clinical Data Scientists and Study Data Managers to understand study scope and expectations.
- Strong experience with clinical study setup and CDMS platforms and CTMS
- Review edit check specifications; write and execute UAT scripts.
- Conduct QC on metadata listings and peer review of programming checks.
- Support automation tool validation and standardization of test scripts.
- Ensure consistent use of clinical data standards across programs and repositories.
- Work with Clinical Data Management Systems (e.g., Medidata Rave, Oracle InForm) to validate database builds and data flows.
- Ensure compliance with GxP/GcP and internal SOPs.
- Document and share study-related testing deliverables and lessons learned
- Solid understanding of SDLC, validation methodology, and document management
Best Regards,
Sanjay Kumar
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