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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