SUMMARY: 4 years of experience in working with both Sponsor and CRO industry focusing on computer systems validation, query management and clinical data management documentation. Worked on creating and handling validation master plan, data management plan, case report forms, change control and data validation specifications. Experience in validation of software's of clinical trial databases, ePRO-electronic patient reported outcome devices and other class I devices. Proficiency in performing Installation, Operational and Performance Qualifications (IQ/OQ and PQ) and data management query review for data quality.

Highlights:

• Documentation
• CFR Part 11
• Management
• Test
• Test Scripts
• Data Management
• Hematology
• User Acceptance Testing
• Acceptance Testing
• Change Control