Study Start up Specialist I
Core
Execute site start-up activities from selection through activation, supporting site maintenance and close-out for clinical trials in the pharmaceutical and biotechnology industry.
Role type
Study Start-Up Specialist I (IC)
Builds
Clinical trial sites activated and maintained for sponsors
Domain
Clinical Research / Pharmaceutical & Biotechnology
Deliverable
client delivery
Required skills
Site start-up management, timeline development and risk analysis, budget drafting and negotiation, Clinical Trial Agreement (CTRA) development, Ethics Committee/IRB submission management, regulatory authority submission drafting, public registry management, investigational product license coordination, essential document collection, audit response, mentoring
Preferred skills
Problem-solving initiative, ability to work under pressure, travel capability
Technologies
None stated
Responsibilities
Develop and manage integrated site start-up timelines; serve as primary contact with Investigator sites, Sponsors, and Project Managers; report status/metrics at sponsor meetings; draft country and site-level budgets and CTAs; manage EC/IEC/IRB submissions and local language materials; draft regulatory authority submissions; manage public registry submissions; oversee investigational product importation licenses; collect essential documents for site activation; participate in and respond to audits; provide guidance to less experienced staff