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Novartis

Expert Solution Architect, Clinical Data Analytics – Technology

Novartis

. Configure and maintain Central Monitoring studies, dashboards, reports, and analytics solutions for assigned studies .

Posted 10/14/2026full-timeHyderabad • IndiaSeniorLeadWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in Central Monitoring, Risk-Based Quality Management, and clinical data analytics, with proficiency in R, Python, SQL, and business intelligence tools. Capable of developing Key Risk Indicators and maintaining compliance with Good Clinical Practice and data privacy regulations.

Highest-signal resume keywords
Central Monitoring Platform ConfigurationRisk-Based Quality ManagementAnalytical Programming Using R, Python, SQLBusiness Intelligence Tools ProficiencyClinical Data Analytics

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Central MonitoringRisk-Based Quality ManagementAnalytical ProgrammingData TransformationStatistical MonitoringAutomation ScriptingQuality Tolerance LimitsKey Risk IndicatorsData ManipulationClinical Data Analytics
Soft Skills
CollaborationProblem-SolvingAttention to DetailTime ManagementCommunication
Tools & Technologies
RPythonSQLPower BISpotfireTableauSASEDCCTMSIRT/IWRS
Industry Keywords
PharmaceuticalBiotechnologyClinical ResearchHealthcare TechnologyGood Clinical PracticeData Privacy RegulationsClinical Data Interchange Standards ConsortiumStudy Data Tabulation ModelAnalysis Data ModelQuality-Control Documentation

Tech Stack

Tools & technologies
PythonSQLTableau

About the role

Key responsibilities & impact
  • Configure and maintain Central Monitoring studies, dashboards, reports, and analytics solutions for assigned studies
  • Develop Key Risk Indicators, Quality Tolerance Limits, risk signals, and statistical outputs/DQA aligned with approved monitoring strategies and specifications
  • Draft Central Monitoring platform specifications and refer to clinical protocols, CRFs, Study ALS, and vendor data transfer specifications
  • Extract, transform, and integrate clinical and operational data for centralized monitoring and risk analytics
  • Test, validate, and quality-check study configurations, dashboards, indicators, and statistical monitoring outputs
  • Support study go-live activities, ongoing maintenance, change requests, troubleshooting, and monitoring updates
  • Develop automation scripts and analytical solutions using R, Python, SQL, or comparable technologies
  • Maintain technical documentation and contribute reusable templates, code libraries, training, and continuous-improvement initiatives
  • Collaborate with clinical, data, central monitoring, and technology teams to strengthen study oversight and data-driven decision-making

Requirements

What you’ll need
  • Seven to ten years of relevant experience in the pharmaceutical, biotechnology, clinical research, or healthcare technology industry
  • Hands-on experience with Risk-Based Quality Management, Central Monitoring, clinical data analytics, reporting, or clinical technology implementation
  • Experience configuring and maintaining Central Monitoring platforms, such as CluePoints or an equivalent solution
  • Experience implementing Key Risk Indicators, Quality Tolerance Limits, risk signals, and statistical monitoring test/DQA approaches for clinical studies
  • Working knowledge of analytical programming using R, Python, Structured Query Language, Statistical Analysis System, or comparable technologies
  • Proficiency with business intelligence and data-visualisation tools such as Power BI, Spotfire, or Tableau
  • Familiarity with electronic data-capture systems, clinical data repositories, metadata-driven environments, and Clinical Data Interchange Standards Consortium standards
  • Understanding of Risk-Based Quality Management, centralised monitoring, Good Clinical Practice, Good Practice quality requirements, and applicable data-privacy regulations
  • 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 such as EDC, CTMS, IRT/IWRS, laboratory, and other third-party data
  • Ability to use 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
  • Desirable: experience developing automated data pipelines, reusable code libraries, and scalable analytical solutions
  • Desirable: experience supporting advanced analytics clinical trial activities
  • Desirable: knowledge of Study Data Tabulation Model and Analysis Data Model standards
  • Desirable: experience supporting quality-control documentation, validation, audit readiness, and regulated system implementation

Benefits

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