Test Manager

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

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