Senior Principal Solution Architect, Clinical Data Analytics & Technology

Novartis; Hyderabad; Hybrid; INR 4,000,000 - 7,000,000; Full time

Job summary

Novartis is seeking a Principal Solution Architect, Clinical Data Analytics & Technology, to design scalable central monitoring analytics and technology solutions for robust trial oversight and data quality. You will lead cross-functional teams, shape monitoring platforms, and implement advanced analytics across studies in a hybrid setup in India (Hyderabad/Mumbai).

The role emphasizes hands-on development, mentoring, and driving automation with AI/ML capabilities within a regulated environment.

Qualifications

• Must have deep experience in Risk-Based Quality Management and clinical data analytics.
• Hands-on experience configuring central monitoring platforms and risk indicators.
• Experience mentoring analytics professionals and leading cross-functional teams.
• Knowledge of ICH E6(R2/R3) and healthcare data privacy regulations is preferred.

Responsibilities

• Lead design and ongoing improvement of Central Monitoring platform configurations and dashboards.
• Develop and govern Key Risk Indicators, Quality Tolerance Limits, risk signals and statistical monitoring models.
• Draft platform specifications referencing protocols, CRFs, study ALS and data transfer specs.
• Ensure platform readiness across multiple trials (3–5 studies) and perform go-live validation.

Skills

RBQM analytics

Central Monitoring

Data integration

Mentoring

Statistical monitoring

Cross-functional leadership

Tools

SAS

SQL

Python

R

CluePoints

Job description

Job Description Summary

Role Type: Hybrid Working, #LI-Hybrid

Primary Location: Hyderabad, India

Other Location: Mumbai, India

Relocation Support: Yes

Job Description

What if your technical leadership could transform how clinical trial risks are detected and managed? As Principal Solution Architect, Clinical Data Analytics & Technology ( RBQM Data Analyst), you will design and deliver scalable central monitoring analytics and technology solutions that strengthen clinical data quality, trial oversight, and operational efficiency. Combining hands-on development with cross-functional leadership, you will shape Central Monitoring platforms, risk indicators, statistical monitoring models, and advanced analytics that enable proactive, data-driven decisions across the clinical studies.

Key Responsibilities

• Lead the design and continuous improvement of Central Monitoring platform configurations and dashboards.
• Develop and govern Key Risk Indicators, Quality Tolerance Limits, risk signals, and statistical monitoring models/ DQA.
• Draft Central monitoring platform specification and refer clinical protocol, CRF, Study ALS and vendor data transfer specification.
• Platform setup, quality control, validation, and go-live readiness across the assigned trials ( 3-5 studies).
• Partner with Clinical, Central monitoring, data management, biostatistics and technology teams to deliver effective analytics strategies.
• Provide technical leadership for data integration, risk analytics, visualisation, troubleshooting, and platform performance.
• Drive automation, standardisation, artificial intelligence, machine learning, and advanced analytics across monitoring operations.
• Mentor Risk-Based Quality Management Data Analysts and strengthen organisational capability through coaching and knowledge sharing.

Essential Requirements

• More than nine to eleven years of relevant experience in the pharmaceutical, biotechnology, clinical research, or healthcare technology industry.
• Extensive experience in Risk-Based Quality Management and clinical data analytics supporting global clinical trials.
• Hands-on experience configuring Central Monitoring platforms, such as CluePoints or an equivalent Risk-Based Quality Management system.
• Demonstrated experience developing and governing Key Risk Indicators, Quality Tolerance Limits, risk signals, and statistical monitoring models (DQA).
• Strong understanding of clinical trial data, centralised monitoring methodologies, data integration, and clinical data-quality oversight.
• Experience mentoring technical or analytics professionals and providing leadership across cross-functional clinical study teams.
• Strong knowledge of International Council for Harmonization E6(R3), risk-based monitoring principles, and clinical trial quality management.
• Proven ability to deliver process improvement, automation, innovation, and scalable analytics solutions within a regulated environment.
• 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 applying artificial intelligence and machine learning to clinical risk detection and monitoring.
• Advanced experience with data visualisation, analytics dashboards, and statistical monitoring methodologies.
• Experience ensuring technology and analytics solutions comply with Good Practice quality requirements and healthcare data-privacy regulations.
• Experience establishing technical standards, governance frameworks, and best practices across a global clinical portfolio.

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

• Classification Methods
• Clinical Trials
• Computer Data Storage
• Computer Programming
• Data Analysis
• Data Reporting
• Data Structures
• Programming Languages
• Statistical Analysis
• Taking Initiative