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