Sumar
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.
About the Role
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.
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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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
