Overview
Data managers design CRFs, implement databases, oversee data entry and cleaning and prepare datasets for analysis and regulatory submission.
Operational Responsibilities
They develop data management plans, run edit checks, reconcile queries with sites and ensure traceability between source documents and trial datasets.
Quality and Compliance
Managers enforce data standards, support audits and ensure adherence to GCP and regulatory requirements for data handling and privacy.
Training and Tools
Data managers use EDC systems, CDISC standards and programming tools and often hold backgrounds in clinical research, biostatistics or informatics.