Associate Director, Clinical Trial Patient Safety
Core
Manage worldwide surveillance of clinical trial patient safety data, ensuring compliant and timely adverse event monitoring and review for assigned compound studies.
Role type
Senior IC clinical safety operations manager (Associate Director)
Builds
Global clinical safety data review processes and inspection-ready environments
Domain
Pharmaceutical industry, clinical drug development, patient safety
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical safety adverse event surveillance, ICH/FDA/EMA regulatory compliance, strategic planning, talent management, SOP implementation, cross-functional project management, drug development lifecycle knowledge
Preferred skills
Graduate degree in healthcare/life sciences, experience in clinical operations or drug safety operations
Technologies
Document management systems, centralized data review tools
Responsibilities
Manage 5 to 10 people; Establish and monitor workload projections and metrics; Partner with medical monitors for safety review oversight; Implement new regulatory requirements and improve department SOPs; Provide oversight of narrative deliverables and issue management; Align communication channels with clinical, regulatory, and pharmacovigilance counterparts
Seniority
Senior, hands-on IC with leadership responsibilities