Job Description
Responsibilities:
Lead data management activities as a program-level lead 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, internal data reviews and vendor key performance indicators.
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 ...