Study Startup Specialist I
Core
Provide direct operational support to project teams to ensure PSI clinical projects start smoothly and on time in France.
Role type
Study Startup Specialist
Builds
Clinical trial startup packages and site activation readiness
Domain
Clinical research / Pharma
Required skills
Site identification, regulatory document review, contract negotiation, budget preparation, stakeholder communication, trial tracking systems management, startup metrics monitoring, process improvement coordination
Preferred skills
None stated
Technologies
eTMF
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 sites regarding startup matters, maintain trial-specific tracking systems and eTMF, monitor startup metrics and timelines, coordinate process improvement initiatives
Seniority
Entry-level (1+ years experience)