Study Startup Lead

PSI CRO·Tokyo or Osaka, Japan

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About the role

Leads clinical study startup activities in Japan from project initiation through site activation. The role supports site selection, regulatory and site submissions, contract and budget negotiation, translations, activation tracking, risk mitigation, CTMS updates, process improvement, team training and mentoring. It uses a hybrid workstyle from the Tokyo or Osaka office and requires full working proficiency in English and Japanese plus prior study and site startup experience in Japan.

Key requirements

• College/University degree or an equivalent combination of education, training and experience
• Required skills: study and site startup in Japan, study startup process leadership, site identification and selection, project and country startup timeline management, study dossier preparation and submission, site contract and budget negotiation, study-specific translation review, site activation progress oversight, clinical project risk mitigation, CTMS tracking, startup process improvement, project team training, staff mentoring, English communication, Japanese communication, communication skills, organizational skills, relationship building and negotiation
• Required languages: English, Japanese

Opportunity details

• Workplace: Hybrid
• Posted: Jun 26, 2026
• Original advert language: English

Full vacancy

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Job title: Study Startup Lead (Tokyo or Osaka)

Location: Tokyo, Japan

Employment type: Full-time

Workplace type: Hybrid

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 1,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

Take your career to the next level and be involved in leading the study startup processes in Japan. You will provide direct operational support to project teams from project start until activation and ensure that PSI clinical projects start smoothly and on time.

Hybrid workstyle (Tokyo or Osaka office)

You will:

Leads all study startup activities/processes with local project teams
Support site identification and selection process
Supports Project Management in developing and updating project/country startup and site activation timelines
Supervises preparation and/or submission of the study dossiers to sites, to the competent authorities, IRBs/IECs, etc.
Leads/Supervises the development and negotiation of site contracts and budgets
Reviews study-specific translations
Oversees and reports on the site activation progress of the clinical sites, including identifying project-specific issues and escalating to all functions concerned
Ensures that project startup targets, site activation timelines and contract deliverables are met, pro-actively addresses risks and supports risk mitigation.
Ensures accurate tracking of startup events in CTMS and other applicable system(s) for the study.
Coordinate initiatives for startup process improvement, analyze best practices and challenges
Trains project teams in startup processes
Mentors department staff in the country
Supports the development and update of manuals, local instructions, and user guides relevant to startup activities within the Country/Region
Participates in process improvement initiatives, testing and implementation of new study startup practices

Qualifications

College/University degree or an equivalent combination of education, training and experience
Prior study and site startup experience in Japan
Full working proficiency in English and Japanese
Communication and organizational skills
Ability to negotiate and build relationships at all levels

Additional Information

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.