Senior Clinical Data Manager

Contribute to data management activities as a lead study data manager in support of Alnylam clinical studies Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews Contribute to development and implementation of department workflows and infrastructure strategy (such as preferred provider interactions, SOPs, and templates) that reflects data collection standards, consistent with industry best practice and regulation Participate in the training of external vendors and site staff Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met Support GCP inspection readiness BS/BA in scientific discipline Extensive related experience in a pharmaceutical/biologics/biotechnology company Experience working in clinical drug development through Phase 3 in an outsourced CRO model; experience with drug development in rare genetic diseases preferred Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems Knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH Experience working with Oracle InForm and Medidata Rave Experience using standardized medical terminology, including MedDRA and WHODrug Experience working with MSOffice Suite (Excel, Word, PowerPoint) and familiarity with MS Project Excellent written and oral communications skills Highly motivated and flexible, with excellent organizational and time management skills Ability to work independently and as part of a multi-disciplinary team Understanding of ICH GCP as well as general knowledge of industry practices and standards Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11 NDA/MAA experience