Study Startup Lead
Core
Leads all study startup activities, feasibility research, site identification, and dossier submission to ensure clinical projects start smoothly and on time in China.
Role type
Senior Study Startup Lead
Builds
Clinical study activation and site readiness
Domain
Clinical Trials / Life Sciences
Required skills
Study startup process management, feasibility research, site identification, eTMF maintenance, site agreement negotiation, regulatory dossier preparation, IRB/IEC submission, site activation tracking, site selection visits, field training
Preferred skills
Leadership, mentoring, organizational skills, communication, relationship building
Technologies
eTMF, IP-REDs
Responsibilities
Lead study startup activities and feasibility research; oversee eTMF maintenance; negotiate site agreements and budgets; review study translations; submit study dossiers to sites and authorities; oversee site activation progress; conduct site selection visits and train SSVs.