Clinical Data SME Tester

11 hours ago

Chennai, India HCLTech Full time

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 managementBest Regards,Sanjay Kumar

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