Expert Solution Architect, Clinical Data Analytics & Technology

Summary

Role Type: Hybrid Working, #LI-Hybrid
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.

 

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, Central Monitoring, clinical data analytics, reporting, or clinical technology implementation.

• Experience configuring and maintaining Central Monitoring platforms, such as CluePoints or an equivalent solution.

• Experience implementing Key Risk Indicators, Quality Tolerance Limits, risk signals, and statistical monitoring test/ DQA approaches for clinical studies.

• Working knowledge of analytical programming using R, Python, Structured Query Language, Statistical Analysis System, or comparable technologies.

• Proficiency with business intelligence and data-visualisation tools such as Power BI, Spotfire, or Tableau.

• Familiarity with electronic data-capture systems, clinical data repositories, metadata-driven environments, and Clinical Data Interchange Standards Consortium standards.

• Understanding of Risk-Based Quality Management, centralised monitoring, Good Clinical Practice, Good Practice quality requirements, and applicable data-privacy regulations.

• Interpret protocols, monitoring plans, quality plans, critical data, endpoints, CtQ factors, risks, and study-specific needs

• Understanding ingestion, harmonization, mapping, transformation and data from different sources like EDC, CTMS, IRT/IWRS, laboratory and other third-party data

• Use SAS, SQL, R, Python or equivalent languages for data manipulation, analytics, automation, and troubleshooting

• Manage setup, go-live, refreshes, change requests, protocol amendments, troubleshooting, and study closeout/archival activities

• Deliver assigned work on time and to first time-right quality standards.

Desirable Requirements

• Experience developing automated data pipelines, reusable code libraries, and scalable analytical solutions.
• Experience supporting advanced analytics clinical trial activities.
• Knowledge of Study Data Tabulation Model and Analysis Data Model standards.
• Experience supporting quality-control documentation, validation, audit readiness, and regulated system implementation.

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

 

Benefits and Rewards

• Learn about all the ways we’ll help you thrive personally and professionally.
• Read our handbook (PDF 30 MB)
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Skills Desired

Clinical Trials, Computer Programming, Data Analysis, Data Reporting, Programming Languages, Statistical Analysis