2 intern jobs found

Position Purpose: The Clinical Data & Applications Manager focuses on governance, review, and validation of deliverables to ensure alignment with CSL standards, regulatory requirements, and industry best practices. The incumbent applies strong expertise in CDASH and SDTM mapping, eCRF development, and EDC systems (e.g., Medidata Rave, Veeva Vault) to validate datasets, specifications, and vendor artifacts. This individual supports cross-functional teams such as Statistics, Data Management and Standards by overseeing and ensuring the quality of clinical data build and programming activities across in-house, hybrid, and vendor-supported studies. The role will contribute to shaping future-state data capabilities by supporting initiatives around scalable data platforms and AI-driven automation, enabling more efficient and intelligent use of clinical data. Reporting Relationships: This role reports to the Director, Statistical Programming Lead Work...

The Principal, Clinical Data Management Lead provides leadership and oversight for clinical data build, programming, and vendor deliverables across in-house, hybrid, and outsourced studies, ensuring alignment with CSL standards, regulatory requirements, and industry best practices . The role drives governance, review, and validation processes; leads the implementation of CDASH and SDTM standards; and oversees scalable validation frameworks and data quality controls . Additionally, it ensures effective integration of internal and external data into platforms such as the CSL Clinical Data Warehouse, while advancing automation, AI-driven solutions, and strong cross-functional collaboration with Biostatistics, Data Management, Standards, and external partners Main Responsibilities and Accountabilities: Leads and develops a team of Clinical Data Validators, providing direction on clinical data standards, validation, and oversight activities across in-house, hybrid, and...