Principal Clinical Data Manager

Role: Principal Clinical Data Manager leading data management activities across all stages of Alnylam's clinical drug development, with emphasis on rare disease programs. Responsibilities: oversee database build, data collection, coding, cleaning, and database lock; collaborate with cross-functional teams including Biostatistics, Clinical Operations, and vendors; review and validate SDTM data and related documentation; develop departmental workflows, SOPs, and standards; participate in inspection readiness and training activities; manage study timelines and deliverables. Requirements: BS/BA in a scientific discipline; 7-9 years of clinical data management experience in pharma/biotech, including Phase 3; expert knowledge of eClinical systems (Medidata Rave) and data standards (CDISC, SDTM, CDASH); experience with regulatory requirements (21 CFR Part 11); strong communication, organizational, and project management skills. Preferred: experience with rare disease drug development, NDA/MAA submissions. HighValue: expertise in clinical data management for biologics or RNAi therapeutics, GCP compliance, SDTM validation, CRO oversight, and regulatory inspection readiness. WorkSetup: not specified.