Senior Associate, Clinical Data Standards Management (CDSM)
Core
Develop, implement, and maintain global clinical data standards and operational data mappings for cancer therapy clinical programs.
Role type
Senior Associate, Clinical Data Standards Management (CDSM)
Builds
Global Library Volume (GLV), eCRFs, edit checks, dynamics, and CRF Completion Guidelines
Domain
Biopharmaceuticals / Clinical Data Management / CDISC Standards
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CDISC standards (CDASH, SDTM), EDC programming, global library development, regulatory compliance (GCP/ICH/FDA/EMA), change management, quality checks
Preferred skills
Medidata Rave modules (Rave Coder, TSDV, ePRO, RSG), process improvement, cross-functional collaboration
Technologies
Medidata RAVE, TrialGrid, Azure, Smartsheet, SharePoint, Veeva Vault
Responsibilities
Support development and maintenance of global clinical data standards; Apply CDISC standards in standards development; Develop and maintain global library objects; Assist in regular releases of the Global Library Volume; Contribute to CRF Completion Guidelines development; Work within multiple technologies to promote development and releases; Support Standards Core and Governance Committee activities; Partner with functional stakeholders to support standards adoption; Identify and suggest process improvements; Ensure compliance with regulatory requirements; Provide study support during initial EDC build; Execute assigned global library build and maintenance activities; Perform quality checks; Document all standards release activities
Seniority
Senior, hands-on contributor
