Director, Clinical Data Management
Core
Oversee data management activities for Alnylam clinical studies across all stages of drug development, managing internal teams and CRO outsourcing strategies.
Role type
Director, Clinical Data Management
Builds
Clinical trial data sets, regulatory documents, and data management infrastructure for Alnylam studies.
Domain
Biopharmaceuticals / Clinical Research
Deliverable
client delivery
Required skills
Clinical data management, CRO management, team leadership, ICH GCP, 21 CFR Part 11, EDC systems, CDISC-SDTM/CDASH, MedDRA/WHODrug
Preferred skills
MS in scientific discipline, global study management experience
Technologies
EDC systems, CDISC standards
Responsibilities
Direct and grow internal data management expertise; establish standards for CRO outsourcing strategy; oversee execution of data management activities (eCRF, database build, cleaning, lock); supervise cross-functional data review plans; lead development of data collection standards; contribute to clinical protocols and regulatory documents; oversee department workflows and infrastructure strategy; ensure compliance of SDTM datasets; certify integrity of clinical data sources; lead GCP inspection readiness efforts.
Seniority
Director, leadership level