Study Startup Specialist II

PSI CRO

  • 北京市 上海市
  • 长期
  • 全职
  • 1天前
Company DescriptionWe 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 DescriptionTake 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/BeijingYou 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 4 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 InformationAdvance 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!

PSI CRO