Senior Manager, Clinical Data Management

Senior Manager, Clinical Data ManagementThe Senior Manager, Clinical Data Management will lead and contribute to data management activities in support of Alnylam studies across all stages of clinical drug development. This position reports to the Director, Clinical Data Management or Associate Director, Clinical Data Management.Summary of Key Responsibilities:Function as program level data management lead in support of Alnylam clinical studies, operating both as an individual contributor and manager of direct reports;Lead oversight of database build activities, including cross-functional review of eCRF content, review of edit check specifications, and performance of user acceptance testing;Monitor data collection, cleaning and coding by CROs via the execution of internal data review plans and review of all vendor data management documentation; provide oversight of all study database lock activities;Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met;Provide strategic guidance to direct reports and internal cross-functional team members regarding data management activities in support of database locks, regulatory submissions and/or other key study deliverables;Train, mentor and oversee work activities of direct reports; provide regular performance review assessments;Author and contribute to development and implementation of departmental standards and infrastructure strategy, such as SOPs, data collection standards and document templates, consistent with industry best practices;Support GCP inspection readiness and participate as subject matter expert in GCP inspections;Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors;Collaborate effectively with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Quality Assurance, Global Patient Safety and Risk Management and Regulatory Affairs; CROs, central laboratories, and other vendors;Review clinical protocols/amendments, clinical study reports, etc.Qualifications:BS/BA in scientific discipline, MS or equivalent preferredAt least 10 years related experience in a pharmaceutical/biologics/biotechnology companyExtensive experience managing global studies through Phase 3 in an outsourced CRO model from start-up through close-out; experience with drug development in rare genetic diseases preferredExperience managing direct reports and providing performance reviews and career development guidanceExperience developing Data Management SOPs and standardsUnderstanding of ICH GCP as well as general knowledge of industry practices and standardsKnowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial data/Data Management SystemsExpert knowledge and understanding of regulations and industry-adopted data standards, such as CDISC-SDTM and CDASHExperience using standardized medical terminology, including MedDRA and WHODrugExperience working with Medidata Rave EDC systemExperience working with MS Office Suite (Excel, Word and PowerPoint), familiarity with MS ProjectExcellent written and oral communication skillsHighly motivated and flexible, with excellent organizational skillsAbility to work independently and as part of a multi-disciplinary teamNDA/MAA submission experience preferredU.S. Pay Range $144,500.00 - $195,500.00