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
Required skills
Feasibility research, site identification, budget negotiation, document collection for regulatory submission, translation coordination, issue escalation, timeline development, staff training
Preferred skills
Relationship building at all levels
Technologies
None stated
Responsibilities
Collaborate with project teams for site activation, assist in feasibility research and site identification, facilitate site agreement and budget negotiations, collect site documents for IRB/IEC submission, coordinate translation of study documents, prepare and submit study dossiers to sites and authorities, prepare IP-RED packages, support initial distribution of investigational products, ensure information exchange with sites and vendors, develop site-specific startup timelines and enrolment projections, train and coach department staff on startup processes
