Study Startup Specialist II/I

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!