Clinical Data SME Tester

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