
Senior Clinical Data Validation Specialist
1 day ago
Clinical Data SME Tester
Key Responsibilities:- A bachelor's degree in life sciences, computer science, or a related field is required.
- With 8+ years of experience in clinical data testing and validation, you will be responsible for performing 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 is essential.
- 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 is necessary.
- In this role, you will utilize your expertise in clinical data testing and validation to ensure the quality and accuracy of data.
- Your strong technical skills and experience working with CDMS platforms and CTMS will enable you to effectively collaborate with cross-functional teams to achieve project goals.
- Perform User Acceptance Testing (UAT) for CRF screens, database edit checks, and exceptional reports/listings.
- Work closely with Clinical Data Scientists and Study Data Managers to understand study scope and expectations, ensuring that all data is processed accurately and efficiently.
- A solid understanding of SDLC, validation methodology, and document management is necessary.
- Experience working with CDMS platforms and CTMS is essential.
- Ability to work independently and maintain attention to detail is required.
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