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Senior Principal Solution Architect, Clinical Data Analytics & Technology

Novartis
Hyderabad, IND
Full-time
Senior · 9–11 years experience
Onsite
Discovered 1 weeks ago
pythonsassql

Full Job Posting

Key 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.
  • Essential 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.
  • 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.
  • 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 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.
  • 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
  • Learn about all the ways we’ll help you thrive personally and professionally.
  • Read our handbook (PDF 30 MB)
  • Skills Desired
  • Classification Methods, Clinical Trials, Computer Data Storage, Computer Programming, Data Analysis, Data Reporting, Data Structures, Programming Languages, Statistical Analysis, Taking Initiative

Qualifications

  • Classification Methods, Clinical Trials, Computer Data Storage, Computer Programming, Data Analysis, Data Reporting, Data Structures, Programming Languages, Statistical Analysis, Taking Initiative
  • 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.
  • 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 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.
  • 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
  • Learn about all the ways we’ll help you thrive personally and professionally.
  • Read our handbook (PDF 30 MB)

Preferred Qualifications

  • Desired
  • Skills Desired

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