Principal Solution Architect, Clinical Data Analytics & Technology

Job Description Summary

Job Description

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

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Skills Desired