PSI CRO

clinical research

StudyStartupSpecialist

Seoul, Seoul, South Korea FULL TIME
The Brief

“Study Startup Specialist at PSI CRO. Skills: Study Startup, Cross-functional Coordination, Vendor/Stakeholder Management. Maintain study-specific and corporate startup tracking systems. Facilitate site budgets and contract negotiations”

What You'll Achieve.

Ensure PSI projects start smoothly and on time.

Industry & Context.

clinical research

What They're Looking For.

Must Have

College/University degree in Life Sciences or an equivalent combination of education, training and experience, 1-2 year of Study Startup experience, 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.

Maintain study-specific and corporate startup tracking systems

Facilitate site budgets and contract negotiations

Support site regulatory document collection

Prepare initial and amendment submission dossiers

Communicate with project team and investigational sites

Develop site specific startup timelines

Meet site activation milestones

Review study specific translations

Supervise Trial Master File (TMF) maintenance

How You'll Work.

Team & Collaboration

Communicate with the project team and investigational sites throughout the entire duration of the study.

Communication Scope

Well-developed communication and organizational skills

Process & Methodology

Develops site specific startup timelines and is responsible for meeting the site activation milestones.

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