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PSI CRO

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!