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1. Strong understanding of 21 CFR part 11, GAMP and standard Good Documentation Practices (GDP) for GxP projects
2. Experience using test management tool, HP ALM and GxP validation approval workflows (either paper or electronic) is a must. 
3. Experience as a tester or test lead in field of clinical trials management or other clinical systems within R&D. 
4. Experience in Xcellerate application is desirable. 
5. Experience with system/functional testing, integrations testing, data migration testing and UAT coordination. 
6. Experience in test script creation and testing in a validated environment.