Lead Tester

This is a fully remote position, open to applicants in India.

📋 Description

• Assist the clinical data management team in the testing and validation of databases used in global clinical research studies.

• Collaborate with clinical data management, programming, study teams, and business stakeholders to ensure that electronic data capture systems are properly configured, tested, and validated.

• Conduct testing and validation of 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 associated study documentation.

• Create and implement test plans, test cases, and test scripts for the validation of clinical databases.

• Carry out functional testing of electronic Case Report Forms, edit checks, integrations, and study workflows.

• Validate both simple and complex edit checks to ensure system functionality and data integrity.

• Identify, document, track, and verify defects through established issue management processes.

• Coordinate and facilitate User Acceptance Testing alongside study teams and business stakeholders.

• Validate defect resolutions and confirm the resolution of testing-related issues.

• Maintain testing documentation and ensure compliance with Good Clinical Practice, standard operating procedures, and regulatory requirements.

• Contribute to ongoing improvements in processes across clinical studies.

⛳️ Requirements

• A bachelor's degree with a minimum of 4 years of experience in clinical database development or testing.

• Practical experience with Medidata Rave and the processes involved in clinical database testing.

• Familiarity with Medidata Rave Classic and/or Medidata Rave EDC.

• Proven experience in developing and executing test plans, test cases, and test scripts for clinical systems.

• Experience in conducting User Acceptance Testing and managing defects.

• Knowledge of Good Clinical Practice, clinical trial procedures, and clinical data management standards.

• Experience in testing clinical databases that support global clinical studies.

• Experience in validating complex edit checks, integrations, and study workflows.

• Ability to work effectively with clinical data management and cross-functional study teams.

• Experience in supporting audit readiness and maintaining regulated testing documentation.

• Experience in contributing to process improvement and quality initiatives within clinical research settings.

🏝️ Benefits

• Medtronic Incentive Plan (MIP) short-term incentive.

• Competitive salary.

• Flexible Benefits Package.

• A comprehensive range of benefits, resources, and competitive compensation plans tailored to support employees at every stage of their career and life.