Study Startup Specialist II
Core
Lead country-level study activation processes to ensure clinical research projects start smoothly and on time.
Role type
Study Startup Specialist
Builds
Clinical trial site activations and project initiation
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Study startup process management, IRB/IEC submission documentation, TMF documentation management, feasibility research, site identification, budget negotiation, translation coordination, project issue escalation, clinical supply distribution, site activation timeline planning
Preferred skills
None stated
Technologies
TMF
Responsibilities
Perform study startup activities and support critical site activation processes; Collect site documents for regulatory submission; File study-specific documentation in TMF; Assist in feasibility research and site identification; Facilitate site agreement and budget negotiations; Coordinate translation and review of study documents; Identify and escalate project issues; Prepare and submit IP-RED packages; Ensure distribution of clinical study supplies to sites; Exchange information with sites, off-site facilities, and vendors; Develop site-specific startup timelines and meet activation targets
Seniority
Mid-level, hands-on IC
