Summary

Role Type: Hybrid Working,

Primary Location: Hyderabad, India

Other Location: Mumbai, India

Relocation Support: Yes

What if your technical expertise could help clinical teams identify risks earlier and protect the quality of clinical trial data? As Expert Solution Architect, Clinical Data Analytics & Technology (RBQM Data Analyst), you will implement and support Risk-Based Quality Management and Central Monitoring solutions across Clinical Data Operations. Working with clinical, data, central monitoring, and technology teams, you will configure monitoring platforms, develop risk indicators and analytics, and deliver scalable solutions that strengthen study oversight and data-driven decision-making.

About The Role

Key Responsibilities

• Configure and maintain Central Monitoring studies, dashboards, reports, and analytics solutions for given studies
• Develop Key Risk Indicators, Quality Tolerance Limits, risk signals, and statistical outputs/DQA aligned with approved monitoring strategies/ Specifications.




• Draft Central monitoring platform specification and refer clinical protocol, CRF, Study ALS and vendor data transfer specification.
• Extract, transform, and integrate clinical and operational data used for centralised monitoring and risk analytics.
• Test, validate, and quality-check study configurations, dashboards, indicators, and statistical monitoring outputs.
• Support study go-live activities, ongoing maintenance, change requests, troubleshooting, and monitoring updates.
• Develop automation scripts and analytical solutions using R, Python, Structured Query Language, or comparable technologies.
• Maintain technical documentation and contribute reusable templates, code libraries, training, and continuous-improvement initiatives.

Essential Requirements

• Seven to ten years of relevant experience in the pharmaceutical, biotechnology, clinical research, or healthcare technology industry.
• Hands-on experience with Risk-Based Quality Management

📌 Expert Solution Architect, Clinical Data Analytics (Mumbai)
🏢 Novartis India
📍 Mumbai