Expert Solution Architect, Clinical Data Analytics & Technology

Job Description Summary

Job Description

Key Responsibilities

• Configure and maintain Central Monitoring studies, dashboards, reports, and analytics solutions for given studies
• Develop Key Risk Indicators, Quality Tolerance Limits, risk signals, and statistical outputs/DQA aligned with approved monitoring strategies/ Specifications.
• Draft Central monitoring platform specification and refer clinical protocol, CRF, Study ALS and vendor data transfer specification.
• Extract, transform, and integrate clinical and operational data used for centralised 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, Structured Query Language, or comparable technologies.
• Maintain technical documentation and contribute reusable templates, code libraries, training, and continuous-improvement initiatives.

Essential Requirements

• 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.

• 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 developing automated data pipelines, reusable code libraries, and scalable analytical solutions.
• Experience supporting advanced analytics clinical trial activities.
• Knowledge of Study Data Tabulation Model and Analysis Data Model standards.
• Experience supporting quality-control documentation, validation, audit readiness, and regulated system implementation.

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.

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Skills Desired