Clinical Data & Applications Manager
Core
Ensures governance, review, and validation of clinical data deliverables to align with CSL standards, regulatory requirements, and industry best practices while supporting scalable data platforms and AI-driven automation.
Role type
Senior Clinical Data & Applications Manager
Builds
Clinical data validation frameworks, standardized reporting libraries, and data visualization solutions for study teams and vendors.
Domain
Pharmaceutical clinical trials / Clinical Data Management (CDM)
Deliverable
production ML models | dashboards & analysis | client delivery
Required skills
CDISC standards (CDASH, SDTM), EDC systems (Medidata Rave, Veeva Vault), eCRF design, data quality control frameworks, SAS, Python/R/C# (automation), vendor deliverable review, pooled data integration
Preferred skills
Advanced analytics, AI-enabled capabilities, scalable data platform development
Technologies
Medidata Rave, Veeva Vault, SAS, Python, R, C#, IxRS
Responsibilities
Provide subject matter expertise on CDASH/SDTM mapping and EDC systems; oversee data quality control frameworks and validation rules; govern standardized reporting libraries; monitor operational reports for accuracy and timeliness; validate clinical data deliverables for submission readiness; lead data visualization solutions; ensure data structures for pooled analyses; integrate external data sources; support AI-enabled data processing initiatives.
Seniority
Senior, hands-on IC with strategic oversight
