Associate Director Clinical Data Management Program Lead
Core
Lead strategic management of Clinical Data Management (CDM) activities across assigned clinical programs to ensure quality, timelines, and budgets are met.
Role type
Senior IC Associate Director, Clinical Data Management Program Lead
Builds
Clinical study data deliverables for biopharmaceutical programs
Domain
Biotechnology / Pharmaceutical / Clinical Research
Required skills
Clinical data management, Program management, Team leadership, Protocol design, Regulatory compliance (21 CFR Part 11, ICH-GCP, CDISC), Risk management, Budget oversight, Inspection readiness, Staff mentoring
Preferred skills
CCDM certification, Virtual team management, Matrix environment navigation
Technologies
Clinical data management systems, Regulatory compliance frameworks
Responsibilities
Lead CDM deliverables across studies, Communicate program status and risks, Provide CDM expertise during protocol design and study conduct, Oversee timelines and budgets, Track metrics and manage Quality Events/CAPAs, Represent CDM in review committees, Drive inspection readiness, Mentor and manage staff
Seniority
Senior, hands-on IC with people management