Study Startup Specialist II/I

PSI CRO·Shanghai or Beijing, China

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About the role

PSI seeks a Study Startup Specialist II/I based in its Shanghai or Beijing office. The role supports country- or regional-level clinical study activation, including budgets and contracts, regulatory submissions, startup timelines, site activation milestones, communications, translations, and TMF maintenance. Applicants need a relevant bachelor's degree, at least two years of site startup experience, strong communication and organizational skills, negotiation and relationship-building ability, and English and Japanese at high business to fluent level.

Key requirements

• Bachelor's degree of Medical, Pharmaceutical or any Life Sciences related major
• At least 2 years of relevant experience
• Required skills: Study startup experience, Study-specific and corporate startup tracking systems, Site budget facilitation, Contract negotiations, Regulatory document collection, Initial submission dossier preparation, Study startup communication, Site-specific startup timelines, Enrollment projections, Site activation milestone management, Trial Master File maintenance, Communication skills, Organizational skills, Negotiation, Relationship building
• Required languages: English, Japanese

Opportunity details

• Workplace: On Site
• Posted: Oct 27, 2026
• Original advert language: English

Full vacancy

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Employer’s role description

Job title: Study Startup Specialist II/I

Location: Shanghai, Beijing, Shanghai, Beijing, China

Employment type: Full-time

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 3000 driven, dedicated and passionate individuals. We work on the front-line of medical science, changing lives, and bringing new medicines to those who need them.

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

Job Description

Take your career to the next level and lead challenging study activation process on a country/regional level. You will support clinical research teams and ensure PSI projects start smoothly and on time.

Office Base: Shanghai or Beijing

You will:

Maintains study-specific and corporate startup tracking systems.
Facilitates site budgets and contract negotiations.
Supports site regulatory document collection.
Under supervision, may prepare initial submission dossiers to competent authorities, ethics committees, and/or site submission dossiers (as applicable).
Communicates with the project team and investigational sites throughout the study startup phase.
Develops site specific startup timelines and enrollment projections 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.

Qualifications

Bachelor's degree of Medical, Pharmaceutical or any Life Sciences related major
At least 2 years site startup experience
Well-developed communication and organizational skills
Ability to negotiate and build relationships at all levels
Leadership, mentoring, and organizational skills
English and Japanese skills (High Business level to Fluent)

Additional Information

Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company, that puts its people first!