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Study Startup Specialist II/I
Shanghai, Beijing, Shanghai, Beijing, CN · On-site · Full-time · Study Startup
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About the role
Clinical ResearchJapaneseLeadership
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.
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.
 
- 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)
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!