Clinical Research Associate - NSW
Core
Provide medical oversight for clinical trials, including protocol review, safety assessment, and data interpretation.
Role type
Senior Medical Monitor (Global/Program level)
Builds
Medical Monitoring Plans, Safety Management Plans, and clinical study reports for Novotech-sponsored trials
Domain
Pharmaceutical/CRO industry, clinical research, pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical degree, clinical practice experience, drug safety reporting knowledge, protocol review, adverse event causality assessment, DSMB participation, medical data trend analysis
Preferred skills
Medical Specialist qualification, drug development experience, mentoring/line management experience
Technologies
CIOMS, MedWatch
Responsibilities
Prepare Medical Monitoring Plans, review client protocols and Investigator Brochures, assess causality for Serious Adverse Events, lead or participate in Data Safety Monitoring Board activities, review individual case safety narratives, interpret medical data trends
Seniority
Senior, hands-on IC with potential line management duties