Clinical Data SME Tester

1 day ago

Malappuram, Kerala, India beBeeClinicalDataValidation Full time ₹ 18,00,000 - ₹ 21,00,000
Expert Clinical Data Validation Specialist

Key Responsibilities:

  • Hold a Bachelor's degree in Life Sciences, Computer Science, or related field.
  • 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.
  • Strong experience with clinical study setup and CDMS platforms and 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 Good eXPractice (GxP)/Good Clinical Practice (GcP) and internal Standard Operating Procedures (SOPs).
  • Document and share study-related testing deliverables and lessons learned.
  • Solid understanding of Software Development Life Cycle (SDLC), validation methodology, and document management.

This position requires the ability to work effectively in a team environment and contribute to the development of high-quality solutions. We are looking for an individual who can demonstrate strong technical skills, excellent communication skills, and a passion for delivering results.

Responsibilities include:

  • Developing and executing testing plans and scripts.
  • Validating data acquisition and ensuring accurate processing.
  • Collaborating with cross-functional teams to identify and prioritize testing needs.
  • Identifying and implementing process improvements.
  • Providing training and support to colleagues as needed.

Benefits of this role include:

  • Opportunity to work on complex and challenging projects.
  • Collaborative and dynamic work environment.
  • Professional development opportunities.
  • Competitive compensation and benefits package.

Additional details about this opportunity can be found below:

  • Job Type: Full-time.
  • Experience: 8+ years.
  • Education: Bachelor's degree in Life Sciences, Computer Science, or related field.
  • Skills:
    • Clinical data testing and validation.
    • User Acceptance Testing (UAT).
    • CRF screens, database edit checks, and exception reports/listings.
    • Clinical study setup configurations.
    • External data acquisition.
    • Clinical Data Management Systems (CDMS).

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