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