Study Startup Specialist II/I
Core
Lead study activation processes on a country/regional level to ensure clinical research projects start smoothly and on time.
Role type
Senior Clinical Research Study Startup Specialist
Builds
Clinical trial study startup activities for pharmaceutical clients
Domain
Clinical Research / Life Sciences
Required skills
Study startup process management, site budget and contract negotiation, regulatory document collection, submission dossier preparation, timeline and enrollment projection, TMF maintenance, translation review
Preferred skills
Leadership, mentoring, relationship building at all levels
Technologies
Trial Master File (TMF), study tracking systems
Responsibilities
Maintain study-specific and corporate startup tracking systems, facilitate site budgets and contract negotiations, support site regulatory document collection, prepare initial submission dossiers to competent authorities and ethics committees, communicate with project teams and investigational sites, develop site-specific startup timelines and enrollment projections, review study-specific translations, supervise Trial Master File (TMF) maintenance
Seniority
Mid-Senior, hands-on IC