Associate Director, Clinical Data Management

Role: Associate Director, Clinical Data Management at Genmab, responsible for overseeing and operationally managing data management activities across clinical trials, supporting data quality and compliance. Responsibilities: lead or co-lead data management efforts, including trial setup, vendor oversight, protocol review, data validation, and reporting; support strategy development, cross-functional collaborations, and process improvements; ensure adherence to GxP, ICH-GCP, and regulatory standards; participate in audits and vendor qualification; mentor colleagues and contribute to departmental initiatives. Requirements: Bachelor's in science or related field; 10+ years in clinical data management within biotech/pharma; extensive hands-on experience across all trial phases, strong knowledge of DM processes and systems, CDISC standards (SDTM), and regulatory compliance; proven leadership in cross-functional teams. High-Value: experience in early and late-stage trials, biologics or antibody modalities, data collection and analysis, vendor oversight, GCP, and regulatory submissions. Work Setup: Not specified, but involves collaboration with internal teams and external vendors.