Senior Manager, Clinical Data Management

Role: Lead and manage clinical data management activities across all stages of Alnylam’s drug development pipeline, supporting studies in rare genetic diseases. Responsibilities: oversee database build, review eCRF content, manage data collection, cleaning, coding, and database lock activities; ensure study milestones are met; provide strategic guidance to team and cross-functional partners; develop departmental standards, SOPs, and infrastructure; support GCP inspection readiness; communicate requirements and timelines; collaborate with internal teams (Biostatistics, Clinical Ops, Regulatory) and vendors (CROs, labs). Qualifications: BS/BA in a scientific discipline, with 10+ years in pharma/biotech, extensive experience managing global Phase 3 studies, with biologics or rare disease focus preferred; proven leadership in direct reports, SOP development, and regulatory compliance; expert knowledge of eClinical systems (Medidata Rave), data standards (CDISC), GCP, 21 CFR Part 11; strong communication and organizational skills. High-Value: expertise in clinical data systems, CDISC standards, Medidata Rave, GCP, and global phase 3 biologics/rare disease studies. WorkSetup: not specified; likely hybrid or onsite based on role scope.