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

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Senior Principal Solution Architect, Clinical Data Analytics & Technology

🗓️ Posted 2026-10-14 2 Locations Hybrid ICT
💰 Salary Not shared 📊 Market 14,500 CHF–19,500 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 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. Job Description

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.

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.
  • ● 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.
  • ● Advanced experience with data visualisation, analytics dashboards, and statistical monitoring methodologies.
  • ● 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)