Study Startup Specialist I
Core
Coordinate clinical study start-up activities in Australia, managing site contracts, regulatory documentation, and activation timelines.
Role type
Clinical Study Startup Specialist
Builds
Clinical trials
Domain
Pharmaceutical clinical research
Deliverable
client delivery
Required skills
Clinical study start-up process, site contract negotiation, regulatory document collection, ethics committee submission support, timeline development, enrollment projection, TMF maintenance
Preferred skills
EC submission experience, pharmaceutical/healthcare degree
Technologies
MS Office (Word, Excel, PowerPoint, Outlook)
Responsibilities
Maintain study tracking systems, facilitate site budgets and contract negotiations, support regulatory document collection, prepare ethics/site submission dossiers under supervision, communicate with project teams and sites, develop startup timelines and enrollment projections, maintain Trial Master File (TMF)
Seniority
Entry-level to Junior
