Study Startup Specialist I
Core
Provide direct operational support to project teams to ensure PSI clinical projects start smoothly and on time.
Role type
Study Startup Specialist
Builds
Clinical trial startup processes for pharmaceutical/medical science projects
Domain
Clinical Research / Pharmaceutical
Required skills
Site identification and selection, Ethics and regulatory document review, Contract and budget negotiation, Trial Master File (eTMF) management, Startup metrics monitoring, Process improvement coordination
Preferred skills
None stated
Technologies
eTMF systems
Responsibilities
Support site identification and selection, Collect and review documents for ethics and regulatory approval, Prepare site documents for drug release, Negotiate site contracts and budgets, Communicate with project teams and review bodies, Maintain trial-specific tracking systems, Monitor startup metrics and timelines
Seniority
Entry-level (1+ years experience)