Expert Solution Architect, Clinical Data Analytics & Technology

IN10 (FCRS = IN010) Novartis Healthcare Private Limited; Hyderabad; Hybrid; INR 2,500,000 - 4,200,000; Full time

Job summary

Novartis Healthcare Private Limited in Hyderabad, India, seeks an Expert Solution Architect, Clinical Data Analytics & Technology (RBQM Data Analyst) to implement and support risk-based quality management and central monitoring solutions across Clinical Data Operations. You will configure monitoring platforms, develop risk indicators and analytics, and deliver scalable data‑driven decision support.

Collaborating with clinical, data, central monitoring, and technology teams, you’ll extract and

Qualifications

• Seven to ten years of relevant experience in pharmaceutical/biotech/clinical research or healthcare technology.
• Hands-on experience with Risk-Based Quality Management, Central Monitoring, clinical data analytics, reporting, or clinical technology implementation.
• Experience configuring Central Monitoring platforms, such as CluePoints or equivalent.
• Experience implementing Key Risk Indicators, Quality Tolerance Limits, risk signals, and statistical monitoring approaches for clinical studies.
• Proficiency with programming languages like R, Python, SQL, SAS for data manipulation and analytics.
• Experience with BI/data-visualization tools such as Power BI, Tableau, or Spotfire.
• Familiarity with EDC systems, clinical data repositories, and CDISC standards; knowledge of data privacy regulations.
• Understanding of RBQM, central monitoring, GCP/GxP, and regulatory requirements.

Responsibilities

• Configure and maintain Central Monitoring studies, dashboards, reports, and analytics for studies.
• Develop Key Risk Indicators, Quality Tolerance Limits, risk signals, and statistical outputs aligned with monitoring strategies.
• Draft platform specifications referencing clinical protocols, CRFs, Study ALS and vendor data transfer specs.
• Extract, transform, and integrate clinical and operational data for monitoring and risk analytics.
• Test, validate, and quality-check study configurations, dashboards, indicators, and monitoring outputs.
• Support go-live activities, ongoing maintenance, change requests, troubleshooting, and monitoring updates.
• Develop automation scripts and analytics using R, Python, SQL or equivalent technologies.
• Maintain technical documentation and reusable templates, code libraries, and training materials.

Skills

Risk-Based Quality Management

Central Monitoring

Clinical Data Analytics

R

Python

SQL

SAS

Power BI

Tableau

CluePoints

Tools

CluePoints

Job description

Job Description 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)

Skills Desired

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

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people's lives.