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Clinical Data Manager
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Full-time
- Responsibilities: Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies.
- Oversight of database lock activities and ultimate archiving of study data Collaborate 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 and local laboratories, and other vendors.
- Establish cross-functional, internal data review plans, coordinate data cuts/transfers, conduct data reviews and oversee data review of team members.
- Collaborate with Statistical Programming to oversee SDTM validation efforts, performing review of validation reports, SDTM Reviewer Guides and define.
- Requirements: BS/BA in scientific discipline At least 8 years of clinical data management experience in a pharmaceutical/biologics/biotechnology company Experience working in clinical drug development through Phase 3 in an outsourced CRO model while serving as program level DM lead; experience with drug development in rare diseases preferred.
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