Mentor peers and contribute to building data science and AI/ML capabilities across the organization.
Apply advanced analytics to patient-level, site-level, and study-level clinical data, processes, and documents to support study design and strategy, execution, oversight, and portfolio insights including potential claims.
Integrate and analyze data across clinical systems (e.g., EDC, CTMS, eTMF, safety systems, external data sources) to provide a holistic view of site and study performance and data reliability.
Evaluate data quality, data risk, and data completeness in the context of clinical trial conduct, identifying potential impacts to patient safety and endpoint integrity.
Ensure analytical approaches align with regulatory authority expectations for electronic records (e.g., data integrity, traceability, reproducibility) and the use of AI in generating outputs.
Apply knowledge of Good Clinical Data Management Practices (GCDMP), and regulatory authority expectations to ensure data is not only complete, but credible and fit for decision-making.
Support inspection readiness through well-documented processes and auditable analytical outputs.
AI & Advanced Analytics Expectations
Demonstrated experience applying machine learning and AI techniques in production or near-production environments
Experience developing predictive models, classification models, or anomaly detection systems
Familiarity with model lifecycle management, including validation, monitoring, and performance evaluation
Ability to identify and implement AI-driven automation or decision-support solutions
Awareness of ethical, regulatory, and governance considerations in AI/ML approaches, development and deployment within clinical research contexts, ensuring alignment with regulatory authority expectations, data privacy requirements, and patient safety considerations.