Study Startup Specialist II/I

Take your career to the next level and lead challenging study activation process on a country/regional level.

About PSI CRO

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!

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.

Responsibilities

• You will support clinical research teams and ensure PSI projects start smoothly and on time.
• 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)