Test Manager
Core
Develop and implement comprehensive test strategies for clinical trial web applications, ensuring compliance with GXP regulations and managing validation for IQ/OQ/PQ phases.
Role type
Senior Test Manager (Clinical Trials)
Builds
Validated clinical trial web applications and regulatory-compliant testing environments
Domain
Healthcare / Clinical Trials / Regulatory Compliance (GXP, GCP, GMP)
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
Test strategy development, Validation Master Plan (VMP) creation, Risk-based testing (GAMP 5), User Acceptance Testing (UAT) coordination, Team leadership, Regulatory compliance (21 CFR Part 11), Data integrity validation, Stakeholder management, Documentation management, Resource allocation
Preferred skills
Experience with clinical trial systems, Knowledge of electronic signatures, Vendor management, Executive reporting
Technologies
Clinical trial web applications, Validation tools, Test management systems
Responsibilities
Develop and implement test strategies for clinical trial web applications, Create validation master plans and protocols, Lead and mentor a team of test engineers, Ensure compliance with GXP guidelines, Oversee functional, integration, and performance testing, Generate validation summary reports and executive dashboards, Collaborate with clinical operations and regulatory affairs teams
Seniority
Senior, hands-on IC with management responsibilities
