Senior Manager, Clinical Data Management
Core
Lead and contribute to data management activities supporting Alnylam's clinical drug development studies across all stages, acting as both a program-level lead and a manager.
Role type
Senior Manager, Clinical Data Management
Builds
Clinical study databases and regulatory submission packages for RNAi therapeutics
Domain
Biotechnology / Clinical Trials / Rare Genetic Diseases
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Global study management (Phase 3), CRO oversight, database build oversight, SOP development, GCP compliance, regulatory submission support, team leadership, EDC system expertise, CDISC standards, medical terminology
Preferred skills
Rare genetic disease drug development, NDA/MAA submission experience
Technologies
Medidata Rave EDC, MS Office Suite, MS Project
Responsibilities
Lead oversight of database build activities including eCRF review and UAT; Monitor data collection and cleaning by CROs; Provide strategic guidance to direct reports and cross-functional teams; Author and implement departmental standards and SOPs; Support GCP inspection readiness; Collaborate with Biostatistics, Clinical Operations, and Regulatory Affairs; Review clinical protocols and study reports.
Seniority
Senior, hands-on IC with management responsibilities
