Overview
The Senior Clinical Data Manager 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 Senior Manager, Data Management.
Summary Of Key Responsibilities
Contribute to data management activities as a lead study data manager in support of Alnylam clinical studies
Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing
Monitor data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews
Oversight of database lock activities and ultimate archiving of study data
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
Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation
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
Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors
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
Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
Support GCP inspection readiness
Demonstrate clear alignment with Alnylam Core Values including, Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence
Qualifications
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
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.