Principal Clinical Data Manager
Core
Lead and contribute to data management activities for Alnylam clinical studies across all stages of drug development, ensuring data quality and regulatory compliance.
Role type
Principal Clinical Data Manager (Program Lead)
Builds
Clinical trial databases and data sets for regulatory submission
Domain
Biopharmaceuticals / Clinical Data Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical data management, EDC system design/build, database lock, SDTM validation, GCP compliance, vendor management, SOP development, cross-functional collaboration, mentorship
Preferred skills
Rare disease drug development experience, Phase 3 outsourced CRO model experience
Technologies
EDC systems, SDTM, define.xml
Responsibilities
Lead database build activities including eCRF review and edit check specifications; Monitor data collection and cleaning by vendors via KPIs; Oversee database lock and archiving; Collaborate with Biostatistics, Programming, and Regulatory Affairs; Establish internal data review plans; Lead development of departmental workflows and SOPs; Mentor internal colleagues and train external vendors; Ensure GCP inspection readiness.
Seniority
Principal, hands-on IC with program-level leadership
