Clinical Data SME Tester

1 week ago

Bengaluru, Karnataka, 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 management

Best Regards,

Sanjay Kumar

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