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Novartis

Senior Principal Solution Architect, Clinical Data Analytics – Technology

Novartis

. Lead the design and continuous improvement of Central Monitoring platform configurations and dashboards .

Posted 10/14/2026full-timeHyderabad • IndiaSeniorWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates extensive experience in Risk-Based Quality Management and clinical data analytics, with a strong focus on Central Monitoring platform configuration and governance. Proven ability to lead cross-functional teams in delivering innovative analytics solutions while ensuring compliance with regulatory standards.

Highest-signal resume keywords
Risk-Based Quality ManagementCentral Monitoring Platform ConfigurationData Integration and AnalyticsStatistical Monitoring ModelsArtificial Intelligence and Machine Learning

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
SASSQLRPythonData VisualizationStatistical MonitoringKey Risk Indicators DevelopmentQuality Tolerance Limits GovernanceClinical Trial Data OversightProcess Improvement
Soft Skills
MentoringLeadershipCollaborationCoachingCommunication
Tools & Technologies
CluePointsEDCCTMSIRT/IWRSAnalytics Dashboards
Industry Keywords
PharmaceuticalBiotechnologyClinical ResearchHealthcare TechnologyInternational Council for Harmonization E6(R3)

Tech Stack

Tools & technologies
PythonSQL

About the role

Key responsibilities & impact
  • 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 specifications and reference clinical protocols, CRFs, Study ALS, and vendor data transfer specifications
  • Perform platform setup, quality control, validation, and go-live readiness across 3–5 assigned studies
  • Partner with Clinical, Central Monitoring, data management, biostatistics, and technology teams to deliver 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 through coaching and knowledge sharing
  • Manage setup, go-live, refreshes, change requests, protocol amendments, troubleshooting, and study closeout/archival activities

Requirements

What you’ll need
  • 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
  • Experience mentoring technical or analytics professionals and providing leadership across cross-functional clinical study teams
  • 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
  • Ability to interpret protocols, monitoring plans, quality plans, critical data, endpoints, CtQ factors, risks, and study-specific needs
  • Understanding of ingestion, harmonization, mapping, transformation, and data from sources including EDC, CTMS, IRT/IWRS, laboratory, and other third-party data
  • Use of SAS, SQL, R, Python, or equivalent languages for data manipulation, analytics, automation, and troubleshooting
  • Ability to manage setup, go-live, refreshes, change requests, protocol amendments, troubleshooting, and study closeout/archival activities
  • Ability to deliver assigned work on time and to first-time-right quality standards
  • Experience applying artificial intelligence and machine learning to clinical risk detection and monitoring
  • Advanced experience with data visualisation, analytics dashboards, and statistical monitoring methodologies
  • Experience ensuring technology and analytics solutions comply with Good Practice quality requirements and healthcare data-privacy regulations
  • Experience establishing technical standards, governance frameworks, and best practices across a global clinical portfolio

Benefits

Comp & perks
  • Relocation Support: Yes
  • Benefits and rewards to help employees thrive personally and professionally