Lead Tester

Job Summary

This role supports the clinical data management function responsible for the testing and validation of clinical study databases used in global clinical research. The team partners with clinical data management, programming, study teams, and business stakeholders to ensure electronic data capture systems are configured, tested, and validated in accordance with study requirements, standard operating procedures, and regulatory expectations.

This is a remote position based in India with no travel requirements. The role focuses on quality assurance activities supporting clinical database development, user acceptance testing, and ongoing process improvements across clinical studies.

The Lead Tester is responsible for testing and validating clinical study databases, electronic case report forms, edit checks, integrations, and study workflows. This role works closely with study teams and stakeholders to ensure systems meet protocol requirements, support user acceptance testing activities, and maintain compliance with Good Clinical Practice and regulatory standards. The position requires hands-on experience with Medidata Rave and clinical database testing processes.

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.

Required Qualifications

• Bachelors degree with 4+ years of experience in clinical database development or clinical database testing.

Preferred Qualifications

• 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.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

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