Senior Manager, Clinical Data Management

Role: Senior Manager, Clinical Data Management, leading data activities across Alnylam's clinical drug development pipeline. Responsibilities: oversee database build, data collection, cleaning, and coding processes; manage CROs and internal teams; ensure timely study database lock; contribute to SOPs and standards; support GCP inspection readiness; collaborate with cross-functional teams including Biostatistics, Clinical Operations, and Regulatory Affairs; review study documentation. Requirements: BS/BA in a scientific discipline; at least 10 years in pharma/biotech, with extensive experience managing global Phase 3 studies in outsourced CRO settings; expertise in eClinical systems, CDISC standards (SDTM, CDASH), Medidata Rave; strong knowledge of GCP, FDA 21 CFR Part 11, and regulatory standards; leadership skills for managing direct reports. Preferred: experience in rare genetic diseases, NDA/MAA submissions. High-Value: experience in biologics/biotech, clinical phases 2-3, GCP/GMP environments, and cross-functional vendor management. Work setup: not specified; likely hybrid or onsite based on industry norms.