Test Manager

As a Test Manager, you will lead a team of test engineers and validation specialists, developing and implementing comprehensive test strategies for clinical trial web applications. Your role involves creating validation master plans and protocols, defining test approaches, and ensuring compliance with GXP, GCP, GLP, GMP, GDP, and GAMP guidelines. You will oversee various testing activities, manage documentation, and coordinate with stakeholders to ensure high-quality and compliant software releases.

Must Have

• Develop and implement comprehensive test strategies for clinical trial web applications.
• Create validation master plans (VMP) and validation protocols in accordance with GXP requirements.
• Define test approach for different validation phases (IQ, OQ, PQ).
• Establish risk-based testing methodologies aligned with GAMP 5 principles.
• Lead and mentor a team of test engineers and validation specialists.
• Ensure all testing activities comply with GXP, GCP, GLP, GMP, GDP, and GAMP guidelines.
• Maintain traceability matrices linking requirements to test cases and defects.
• Oversee functional, integration, system, and performance testing.
• Validate data integrity, security, and audit trail functionality.
• Ensure proper testing of electronic signatures and 21 CFR Part 11 compliance.
• Create and maintain comprehensive test documentation.
• Generate validation summary reports and executive dashboards.
• Document deviations, CAPAs, and change controls.
• Collaborate with clinical operations, data management, and biostatistics teams.

Experience 9 to 12 years

• Develop and implement comprehensive test strategies for clinical trial web applications
• Create validation master plans VMP and validation protocols in accordance with GXP requirements
• Define test approach for different validation phases IQ OQ PQ
• Establish risk based testing methodologies aligned with GAMP 5 principles
• Plan and coordinate User Acceptance Testing UAT with clinical stakeholders

Team Leadership Management

• Lead and mentor a team of test engineers and validation specialists
• Assign tasks and monitor team performance against project timelines
• Conduct regular team meetings and provide technical guidance
• Foster collaboration between testing development and quality assurance teams
• Manage resource allocation and capacity planning

Compliance Quality Assurance

• Ensure all testing activities comply with GXP GCP GLP GMP GDP and GAMP guidelines
• Maintain traceability matrices linking requirements to test cases and defects
• Review and approve validation documentation including test plans protocols and reports
• Coordinate with QA teams for regulatory inspections and audits
• Implement and maintain quality metrics and KPIs

Technical Testing Activities

• Oversee functional integration system and performance testing
• Validate data integrity security and audit trail functionality
• Ensure proper testing of electronic signatures and 21 CFR Part 11 compliance
• Coordinate testing of system interfaces and data migrations
• Manage testing environments and test data provisioning

Documentation Reporting

• Create and maintain comprehensive test documentation
• Generate validation summary reports and executive dashboards
• Document deviations CAPAs Corrective and Preventive Actions and change controls
• Ensure proper version control and document management
• Provide regular status reports to stakeholders and senior management

Stakeholder Management

• Collaborate with clinical operations data management and biostatistics teams
• Interface with regulatory affairs and quality assurance departments
• Coordinate with vendors and third party service providers
• Present testing results and validation status to executive leadership