Director, Clinical Data Management

Summary The Director, Clinical Data Management is responsible for the oversight of data management activities in support of Alnylam studies across all stages of clinical drug development. This position reports to the head of the Clinical Data & Insights group. Responsibilities: Direct and grow internal data management expertise area, including management of direct reports; Direct and establish standards for data management CRO outsourcing strategy and deliverables, including the CRO selection process and the governance of CRO performance; Oversee the successful execution of all data management activities in support of Alnylam clinical studies in partnership with CROs, including eCRF development, database build, data collection, data coding, cleaning, database lock and archiving; Supervise the execution of cross-functional, internal data review plans by direct reports across all Alnylam clinical studies; Partner with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Clinical Pharmacology and Pharmacometrics, Bioanalytical, Safety & Risk Management (SRM) and Regulatory Affairs; CROs, central and local laboratories, and other vendors; Lead development and implementation of data collection standards, consistent with industry best practice; Lead data management contributions to the development of clinical protocols, clinical study reports and other regulatory documents, e.g. DSURs, Briefing Documents, etc. Oversee development of department workflows, and infrastructure strategy and implementation, such as preferred provider initiatives, SOPs, and templates; Collaborate with Statistical Programming and external vendors to ensure compliance of SDTM clinical datasets, consistent with CDISC standards; Collaborate with Clinical Operations and Quality Assurance to certify the integrity and traceability of all clinical data sources, compliant with 21 CFR Part 11 standards; Direct Data Management GC