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Job Description Summary
#LI-Hybrid
Job Description
Key Responsibilities:
Transform complex clinical data into intelligent, actionable insights that inform decision-making across Clinical Trial Teams
Drive collaboration across Data Quality Teams to enhance data strategy, data quality, site experience, and patient safety utilizing the Disease Area, Data Standards & Protocol Knowledge.
Partner with Central Monitoring (CM) and Data Management) Leads to promote risk-based data review approaches within CDO.
Leverage data analytics and visualisation tools such as Power BI and Spotfire to uncover trends, patterns, and emerging risks
Contribute to advanced data quality initiatives such as anomaly detection and continuous improvement of insight generation capabilities
Drive risk‑based analytics by proactively identifying Critical-to-Quality (CtQ) risks and prioritizing data review through advanced analytical approaches.
Implement operational interventions that enhance data quality and accelerate study cycle times.
Essential Requirements:
Extensive experience in clinical data operations within clinical trials, with strong understanding of clinical trial delivery. Ideally a minimum of 10-12 years working experience in a Life Sciences environment with extensive exposure to Clinical Trials and Clinical Operations
Proven track record in driving operational excellence within pharmaceutical or clinical research environments
Proven industry-based experience in clinical data management, clinical programming, RbQM, analytics, and technology transformation.
Strong ability to generate intelligent, data-driven insights and influence decision-making across clinical teams
Experience using data visualisation tools such as Power BI, Spotfire, or similar platforms to uncover trends and insights
Demonstrated capability in data storytelling, translating complex data into clear, impactful narratives for stakeholders
Knowledge of technology transformation, including automation, cloud platforms, and business intelligence tools, with awareness of programming languages such as SAS, R, or Python
Strong understanding of clinical data technologies (e.g. EDC, clinical data hub, statistical computing environment, metadata management tools, J-Review), data standards such as Clinical Data Interchange Standards (Consortium Study Data Tabulation Model and Analysis Data Model), and regulatory compliance and data governance requirements
Fluent written and verbal English essential
Skills Desired
Business Intelligence (BI), Business Intelligence (BI), Classification Systems, Clinical Operations, Clinical Trials, Clinical Trials Analysis, Clinical Trials Operations, Computer Data Storage, Computer Programming, Cross-Functional Teams, Data Analysis, Data Analytics, Data Insights, Data Quality, Data Structures, Initiative, powerbi, Programming Languages, Python (Programming Language), R Analytics, Reporting, risk based quality management, R Programming, R Statistics, SAS Statistics {+ 1 more}Novartis Ag
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