425953 Senior Analyst - Validation (Open)

Job Summary

The Senior Analyst - Validation is responsible for preparing and executing test scripts for rules validation within the ECD and CDB systems. This role ensures that all components are thoroughly tested to meet technical requirements and contributes to the overall validation strategy by collaborating with various project teams.

Responsibilities

• Prepare and execute test scripts for rules validation for ECD and CDB systems.
• Ensure components are properly tested to meet technical requirements.
• Create validation guidance, best working practices, and process documentation.
• Write and review User Acceptance Test scripts.
• Assist in building an automation testing framework while enhancing existing automation tests.
• Create and implement the Quality plan at the study level.
• Assist in the study-level validation of Libraries and Templates.
• Ensure all validation-related documents are accurate and present in the electronic Trial Master File (eTMF) system.
• Support activities for process and tool improvement.
• Contribute to the validation strategy by working with representatives from multiple project teams, including clinical data standards, statistics, and programming.

Qualifications

• Bachelor's degree in a relevant field (e.g., Computer Science, Information Technology, or related discipline).
• Strong understanding of clinical data management processes.
• Experience in preparing and executing test scripts and validation documentation.
• Proficiency in automation testing frameworks and tools.
• Excellent analytical and problem-solving skills.
• Strong communication and collaboration skills to work with cross-functional teams.
• Ability to act as a Subject Matter Expert (SME), mentor, and technical advisor on complex concerns.
• Sufficient level of autonomy in managing highly complex study setups with multiple stakeholders.

Experience

• Proven experience in delivering assigned clinical data management tasks in line with expectations regarding time and quality.
• Experience acting as a mentor and technical advisor on complex issues.

Environment

• Work location: Bengaluru Luxor North Tower.
• Work type: Full-time.
• Work mode: Hybrid.

Salary

• Estimated salary range: ₹4,000,000.

Growth Opportunities

• Opportunities for career advancement within the organization, particularly in clinical data management and validation roles.