Principal Clinical Data Manager

Role: Principal Clinical Data Manager leading data management activities across all stages of Alnylam's clinical studies, with a focus on rare disease drug development. Responsibilities: oversee database build, data collection, coding, cleaning, and database lock; collaborate with internal teams (Biostatistics, Clinical Operations, QA, Regulatory) and external vendors; develop data review plans, review SDTM validation, and lead GCP inspection readiness for Data Management; mentor staff and participate in documentation review and process improvements. Qualifications: BS/BA in a scientific discipline; 7-9 years' clinical data management experience in pharma/biotech; expertise in eClinical systems (Medidata Rave preferred), SDTM/CDISC standards, and GCP regulations; experience with Phase 3 clinical trials in rare diseases; strong communication, organizational, and project management skills. HighValue: leadership in program-level data management, SDTM validation, GCP inspection readiness, experience in biologics or RNAi therapeutics preferred. WorkSetup: not specified, but likely in a collaborative, cross-functional environment, with involvement in vendor oversight.