Regulatory Services Manager - National Center for Clinical Trials (NCCT)
Core
Provides administrative direction and coordination of Regulatory Services for clinical research, ensuring compliance with institutional, IRB, federal, and other applicable regulatory requirements across a large number of clinical trials.
Role type
Senior Regulatory Services Manager
Builds
Compliant and efficient clinical research operations and regulatory workflows
Domain
Healthcare / Clinical Research / Regulatory Affairs
Deliverable
dashboards & analysis
Required skills
Regulatory compliance (GCP, ICH, FDA, HIPAA), IRB submission management, audit and inspection response, staff leadership and performance management, policy development, risk assessment, stakeholder communication
Preferred skills
Medical/research environment experience, knowledge of scientific and statistical principles
Technologies
None stated
Responsibilities
Provide administrative oversight and direct leadership to regulatory staff; oversee regulatory submissions and approvals (IRB reviews, amendments, closures); ensure compliance with regulations (GCP, ICH, FDA, OHRP, HIPAA); prepare for and manage internal and external audits and inspections; monitor regulatory projects and workflows; communicate regulatory status and risks to investigators and leadership; monitor regulatory changes and lead implementation of process changes; support protocol development and study start-up/close-out activities.
Seniority
Senior, hands-on IC with management responsibilities
