Lead Tester
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Job Description
Lead Tester validating clinical databases, eCRFs, edit checks, and workflows for Medtronic’s global healthcare technology business. Supporting regulated clinical research testing and user acceptance activities remotely from India.
Responsibilities:
- Review study protocols, specifications, electronic Case Report Form (eCRF) design documents, and related study documentation to understand system requirements
- Develop and execute test plans, test cases, and test scripts for clinical database validation activities
- Perform functional testing of electronic Case Report Forms, edit checks, integrations, and study workflows
- Validate simple and complex edit checks to ensure accurate system functionality and data quality
- Identify, document, track, and verify defects through established issue management processes
- Coordinate and support User Acceptance Testing activities with study teams and business stakeholders
- Validate defect fixes and confirm successful resolution of issues identified during testing cycles
- Maintain testing documentation and ensure compliance with Good Clinical Practice, standard operating procedures, and applicable regulatory requirements
Requirements:
- Bachelor's degree with 4+ years of experience in clinical database development or clinical database testing
- Experience with Medidata Rave Classic and/or Medidata Rave EDC
- Experience developing and executing test plans, test cases, and test scripts for clinical systems
- Experience performing User Acceptance Testing and defect management activities
- Knowledge of Good Clinical Practice, clinical trial processes, and clinical data management standards
- Experience testing clinical databases supporting global clinical studies
- Experience validating complex edit checks, integrations, and study workflows
- Experience working with clinical data management and cross-functional study teams
- Experience supporting audit readiness and regulated testing documentation
- Experience contributing to process improvement and quality initiatives within clinical research environments
Benefits:
- Medtronic offers a competitive Salary and flexible Benefits Package
- Short-term incentive called the Medtronic Incentive Plan (MIP)
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