Back to jobsContribute 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
