Clinical Data Validation Expert

10 hours ago

Rajkot, Gujarat, India beBeeClinicalDataSpecialist Full time ₹ 15,00,000 - ₹ 25,00,000
Clinical Data SME Tester Job Description

This is a specialized role for professionals with expertise in clinical data testing, validation, and management.

Key Responsibilities:
  • Hold a Bachelor’s degree in Life Sciences, Computer Science, or a related field.
  • Possess 8+ years of experience in clinical data testing and validation.
  • Perform User Acceptance Testing (UAT) for CRF screens, database edit checks, and exception 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.
  • Have strong experience with clinical study setup and CDMS platforms, as well as CTMS.
  • Review edit check specifications; write and execute UAT scripts.
  • Conduct quality control 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.
  • Possess a solid understanding of SDLC, validation methodology, and document management.

This role requires excellent communication skills, the ability to work independently, and strong problem-solving abilities.

The ideal candidate will have a strong background in clinical data testing, validation, and management.

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