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Principal Solution Architect, Clinical Data Analytics & TechnologyNovartis · 2 Locations
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Novartis

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Principal Solution Architect, Clinical Data Analytics & Technology

🗓️ Posted 2026-10-14 2 Locations Hybrid ICT
💰 Salary Not shared 📊 Market 13,500 CHF–18,500 CHF/mo

About the Company

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. Job Description

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

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.
  • ● Advanced knowledge of unsupervised statistical testing and approaches for improving signal quality and reducing false positives.
  • ● 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

  • ● Learn about all the ways we'll help you thrive personally and professionally.
  • ● Read our handbook (PDF 30 MB)