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Detailed Job Description:

• Overall experience of 10 years with specialized in Testing and Validation of eTMS and eQMS system development and implementation.
• Min. of 6+ years of experience in eTMF (Trial Master Files), eQMS / eDQMS (Quality Management System) is mandatory
• Min. of 6+ years of experience in Validation, Clinical Trial experience, MF ALM is mandatory
• Min. of 6+ Testing and Validation of eTMS and eQMS system development and implementation is mandatory.

Testing Activity Details:

Test Strategy, Planning and Management:

• Create test strategy and plan. Update document based on dynamics of the project.
• Identify and manage risk from testing perspective
• Engage early and proactively with project team to find defects early in the lifecycle
• Identify and provide technical recommendation to improve quality of the build
• Coordinate with offshore team members for timely progress of testing related activities
• Review testing deliverables created by offshore team members to ensure accuracy and validity in-line with test strategy, plan and overall program requirements.
• Plan and oversee data testing automation using tool provided by Exelixis
• Identify continuous improvement opportunities and review with Exelixis for implementation

Test Preparation:

• Create detailed test cases for all scenarios (drafted so far and to be drafted)
• Create Scenarios and test cases for Data Quality checks in-pipeline
• Create Negative testing scenarios
• Create Query repository and map to test case for execution
• Test Data planning and preparation
• Test Environment planning and coordination to ensure availability on-time.
• Create test execution plan
• Coordinate with project team members for progress, review and updates

Test Execution:

• Execute test cases, report defects, re-test defects, oversee execution by offshore team members
• Coordinate for clarifications, defect resolution
• UAT coordination and support
• Conduct daily testing stand-ups
• Send Daily Status report
• Coordinate with project team members for progress, review and updates

Minimum years of experience required? 10+