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Entry LevelFull-timeGCP
Salary Range
$5,100 - $6,900 /year
This salary is estimated based on similar roles. The actual salary may vary.
About the Role
We are seeking an experienced Clinical Trial Testing Manager to lead testing and validation activities for clinical trial web applications. This role requires extensive knowledge of GXP, GCP, GLP, GMP, GDP, and GAMP guidelines.
Key Responsibilities
- →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
- →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
- →Oversee functional, integration, system, and performance testing
- →Validate data integrity, security, and audit trail functionality
- →Generate validation summary reports and executive dashboards
Requirements
- ✓9 to 12 years of experience in clinical trial testing and validation
- ✓Strong understanding of GXP, GCP, GLP, GMP, GDP, and GAMP guidelines
- ✓Experience with validation master plans and protocols
- ✓Knowledge of IQ, OQ, PQ validation phases
- ✓Familiarity with GAMP 5 principles
- ✓Experience with User Acceptance Testing (UAT)
- ✓Team leadership and management experience
- ✓Understanding of 21 CFR Part 11 compliance
- ✓Experience with documentation and reporting in clinical testing environments
- ✓Ability to coordinate with QA teams for regulatory inspections and audits
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