Lead Tester
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Job Description
Lead Tester validating clinical databases, eCRFs, edit checks, and integrations for Medtronic’s global healthcare technology research. Supporting user acceptance testing and regulatory compliance remotely from India.
Responsibilities:
- Support the clinical data management function responsible for testing and validation of clinical study databases used in global clinical research
- Partner with clinical data management, programming, study teams, and business stakeholders to ensure electronic data capture systems are configured, tested, and validated
- Test and validate clinical study databases, electronic case report forms, edit checks, integrations, and study workflows
- Review study protocols, specifications, electronic Case Report Form (eCRF) design documents, and related study documentation
- Develop and execute test plans, test cases, and test scripts for clinical database validation
- Perform functional testing of electronic Case Report Forms, edit checks, integrations, and study workflows
- Validate simple and complex edit checks for system functionality and data quality
- Identify, document, track, and verify defects through issue management processes
- Coordinate and support User Acceptance Testing with study teams and business stakeholders
- Validate defect fixes and confirm resolution of testing issues
- Maintain testing documentation and compliance with Good Clinical Practice, standard operating procedures, and regulatory requirements
- Contribute to ongoing process improvements across clinical studies
Requirements:
- Bachelor's degree with 4+ years of experience in clinical database development or clinical database testing
- Hands-on experience with Medidata Rave and clinical database testing processes
- 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 Incentive Plan (MIP) short-term incentive
- Competitive salary
- Flexible Benefits Package
- Wide range of benefits, resources, and competitive compensation plans designed to support employees at every career and life stage
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