PSI CRO
Life Sciences
StudyStartupSpecialistI/II
“Study Startup Specialist I/II at PSI CRO. Skills: Study Startup, process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. Maintains study-specific and corporate startup tracking systems. Facilitates site budgets and contract negotiations”
What You'll Achieve.
ensure PSI projects start smoothly and on time; meeting the site activation milestones
Industry & Context.
What They're Looking For.
Must Have
At least 2-3 year of Study Startup experience in the Korea, Well-developed communication and organizational skills, Ability to negotiate and build relationships at all levels, Leadership, mentoring, and organizational skills, Proficiency in Korean and English language
What You'll Do.
Maintains study-specific and corporate startup tracking systems
Facilitates site budgets and contract negotiations
Supports site regulatory document collection
may prepare initial and amendment submission dossiers to competent authorities
and/or site submission dossiers (as applicable)
Communicates with the project team and investigational sites throughout the entire duration of the study
Develops site specific startup timelines and is responsible for meeting the site activation milestones
May review study specific translations
Supervises Trial Master File (TMF) maintenance throughout the study startup phase
How You'll Work.
Team & Collaboration
Communicates with the project team and investigational sites throughout the entire duration of the study; cross-functional coordination
Communication Scope
Well-developed communication and organizational skills; Proficiency in Korean and English language; Communicates with the project team and investigational sites
Process & Methodology
Develops site specific startup timelines and is responsible for meeting the site activation milestones, process management
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