Principal 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 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