Clinical Trials Program Manager – Australia
Core
Lead clinical trial operations in Australia for a biotech developing vaccines and therapeutics, serving as the primary on-ground contact for clinical sites and regulatory bodies.
Role type
Clinical Trials Program Manager (Site Coordinator)
Builds
Clinical trial infrastructure and execution for Phase I vaccines and therapeutics
Domain
Biotechnology / Clinical Trials / Infectious Diseases / Oncology
Deliverable
client delivery
Required skills
Clinical trial coordination, site initiation/monitoring/close-out visits, investigational product shipping compliance, TMF/eTMF management, electronic data capture setup, HREC application preparation, CTN submission, ANZCTR registration, SAE/SUSAR reporting, trial expense tracking, vendor management
Preferred skills
CRO or sponsor-side experience, Phase I trial experience, knowledge of Australian clinical trial regulations (TGA, ANZCTR, HREC)
Technologies
AI-enabled clinical trial operations software, electronic data capture platforms
Responsibilities
Lead site initiation, monitoring, and close-out visits; coordinate investigational product shipping; manage TMF/eTMF; oversee electronic data capture setup and data cleaning; prepare HREC applications and respond to comments; submit Clinical Trial Notifications (CTNs); register trials on ANZCTR; report SAE/SUSAR to HREC and TGA; maintain trial expense records; manage relationships with software vendors and CROs
Seniority
Mid-level, hands-on IC
