Study Startup Specialist II (18-months contract)
Core
Lead the study activation process for clinical research projects in Australia, ensuring projects start smoothly and on time.
Role type
Study Startup Specialist
Builds
Clinical research study activations for pharmaceutical clients
Domain
Clinical research / Pharmaceutical industry
Deliverable
client delivery
Required skills
Study startup process management, site budget and contract negotiation, regulatory document collection, submission dossier preparation, site timeline and enrollment projection development, TMF maintenance
Preferred skills
Pharmaceutical/healthcare domain knowledge
Technologies
MS Office (Word, Excel, PowerPoint, Outlook)
Responsibilities
Maintain study-specific and corporate startup tracking systems; Facilitate site budgets and contract negotiations; Support site regulatory document collection; Prepare initial and amendment submission dossiers under supervision; Communicate with project teams and investigational sites; Develop site-specific startup timelines and enrollment projections; Supervise Trial Master File (TMF) maintenance
Seniority
Mid-level specialist
