Principal Solution Architect, Clinical Data Analytics & Technology

IN10 (FCRS = IN010) Novartis Healthcare Private Limited; Hyderabad; Hybrid; INR 3,500,000 - 5,500,000; Full time

Benefits offered by this job

Hybrid working

Relocation support

Job summary

Novartis Healthcare Private Limited seeks a Senior Principal Solution Architect for Clinical Data Analytics & Technology. You will design scalable central monitoring analytics, shape monitoring platforms, indicators, models, and automation to improve trial oversight and data quality.

You will collaborate with Clinical, data management, biostatistics, and technology teams to deliver analytics strategies and drive AI/automation initiatives across portfolios.

Qualifications

• 12+ years of pharma/clinical data analytics or healthcare tech experience.
• Experience delivering central monitoring and RBQM solutions across studies.
• Hands-on experience configuring monitoring platforms, dashboards, and reporting.
• Proven ability to translate KRIs/QTLs into platform outputs.
• Strong data integration, transformation, and analytics troubleshooting skills.

Responsibilities

• Lead Central Monitoring platform configuration for an assigned portfolio.
• Design and maintain KRIs, QTLs, risk signals, and monitoring models.
• Develop and maintain KRIs, QTL library and platform specifications.
• Deliver end-to-end configuration, validation, and go-live activities.
• Collaborate with Clinical, data management, biostatistics, and IT teams.
• Resolve data integration and visualization issues; optimize risk signals.
• Advance AI, automation, and ML approaches for risk detection.
• Provide technical guidance and mentorship to team members.
• Drive AI, automation, and future-state analytics strategy.
• Manage vendor relationships and stakeholder expectations.

Skills

Central Monitoring

KRIs & QTL

Risk-Based Quality Management

SAS

SQL

Python

Data Analytics

Leadership

Stakeholder Management

Cloud/Automation

Education

Bachelor's degree or higher in a relevant field

Tools

SAS

SQL

R

Python

Job description

Band Level 4 Job Description Summary

Role Type: Hybrid working, #LI-Hybrid

Primary Location: Hyderabad, India

Other Location: Mumbai, India

Relocation Support: Yes

What if your technical leadership could transform how clinical trial risks are detected and managed across an entire portfolio? As Senior 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 technical expertise with portfolio leadership, you will shape monitoring platforms, risk indicators, statistical models, automation, and advanced analytics that strengthen data quality, improve operational efficiency, and enable proactive decision-making across Clinical Portfolio.

Key Responsibilities

• Lead Central Monitoring platform configuration across an assigned portfolio of clinical studies.
• Design and maintain Key Risk Indicators, Quality Tolerance Limits, risk signals, and statistical monitoring models.
• Develop and support maintenance of KRIs, QTL library Draft Central monitoring platform specification and refer clinical protocol, CRF, Study ALS and vendor data transfer specification.
• Deliver end-to-end platform configuration, validation, user acceptance testing, and study go-live activities.
• Partner with Clinical, Central monitoring, data management, biostatistics and technology teams to deliver effective analytics strategies.
• Resolve complex data integration, transformation, visualisation, platform, and risk-signal generation issues.
• Advance automation, artificial intelligence, machine learning, and statistical approaches to improve risk detection.
• Simply central monitoring platform development.
• Provide technical guidance, training, and knowledge sharing to members within team.
• Driving AI, automation and future-state analytics strategy.
• Managing relationships with vendors and key stakeholders.
• Defining success measures and driving key objectives within team.
• Scaling the capability across the portfolio.

Essential Requirements

• More than 12-14 years of extensive relevant experience in pharmaceutical development, clinical research, data analytics, or healthcare technology.
• Strong experience delivering Risk-Based Quality Management and Central Monitoring solutions across clinical trial portfolios.
• Hands-on expertise configuring Central Monitoring platforms, analytics modules, dashboards, and reporting solutions.
• Demonstrated experience developing Key Risk Indicators, Quality Tolerance Limits, risk signals, and statistical monitoring models.
• Ability to translate complex KRIs and QTL requirements and support such output development in platform.
• Strong knowledge of clinical data integration, transformation, visualisation, validation, and analytical troubleshooting.
• Strong knowledge of International Council for Harmonization E6(R3), risk-based monitoring principles, and clinical trial quality management.
• Strong leadership, communication, and stakeholder-management skills, with the ability to guide teams in a global matrix 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 implementing artificial intelligence, machine learning, automation, or advanced statistical monitoring solutions.
• Advanced knowledge of unsupervised statistical testing and approaches for improving signal quality and reducing false positives.
• Experience leading technical delivery across a portfolio of global clinical studies.
• Experience providing technical coaching, training, and guidance to junior colleagues and cross-functional stakeholders.

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

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.

In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .