Lead Data Manager
Core
Lead end-to-end clinical data management start-up activities from protocol review through database go-live to ensure compliant study configuration and meaningful insights.
Role type
Lead Data Manager (Clinical Research)
Builds
Clinical trial databases and study build specifications
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Clinical data management, protocol review, CDISC standards, eCRF design, statistical software, data visualization, project leadership, risk assessment, timeline management, regulatory compliance (ICH-GCP)
Preferred skills
Team development, cross-functional collaboration, protocol amendment management
Technologies
eCRF, eTMF, statistical software, data visualization tools
Responsibilities
Lead end-to-end clinical data management start-up activities; Review protocols to identify data collection requirements and risks; Translate requirements into study build specifications; Apply clinical data standards (CDISC); Partner with Standards team to define modifications; Collaborate with cross-functional stakeholders; Plan and oversee sandbox and UAT; Manage start-up timelines and dependencies; Assess impact of protocol amendments; Maintain data management documentation in eTMF.
Seniority
Senior, hands-on IC with team leadership