Study Startup Specialist II
Core
Lead country-level study activation processes to ensure clinical research projects start smoothly and on time.
Role type
Senior Study Startup Specialist
Builds
Study dossiers, IP-RED packages, and site activation timelines for clinical trials
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Site activation process management, contract negotiation, budget negotiation, IRB/IEC submission coordination, IP-RED package preparation, study supply distribution, timeline development, enrollment projection analysis
Preferred skills
Relationship building at all levels, issue escalation
Technologies
None stated
Responsibilities
Collaborate with project teams on site activation, facilitate site agreements and negotiations, collect documents for regulatory submissions, coordinate document translation, prepare and submit study dossiers, support investigational product distribution, manage information exchange with sites and vendors, develop site-specific startup timelines and enrollment projections
Seniority
Mid-Senior, hands-on IC
