Expert Solution Architect, Clinical Data Analytics & Technology

Job Description Summary Role Type: Hybrid Working, #LI-Hybrid Primary Location: Hyderabad, India Other Location: Mumbai, India Relocation Support: Yes What if your technical expertise could help clinical teams identify risks earlier and protect the quality of clinical trial data? As Expert Solution Architect, Clinical Data Analytics & Technology (RBQM Data Analyst), you will implement and support Risk-Based Quality Management and Central Monitoring solutions across Clinical Data Operations. Working with clinical, data, central monitoring, and technology teams, you will configure monitoring platforms, develop risk indicators and analytics, and deliver scalable solutions that strengthen study oversight and data-driven decision-making. 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.