Study Startup Lead

【求人No NJB2302347】
Take your career to the next level and be involved in leading the study startup processes in Japan. You will provide direct operational support to project teams from project start until activation and ensure that PSI clinical projects start smoothly and on time.

You will:

・Leads all study startup activities/processes with local project teams
・Support site identification and selection process
・Supports Project Management in developing and updating project/country startup and site activation timelines
・Supervises preparation and/or submission of the study dossiers to sites to the competent authorities IRBs/IECs etc.
・Leads/Supervises the development and negotiation of site contracts and budgets
・Reviews study specific translations
・Oversees and reports on the site activation progress of the clinical sites including identifying project specific issues and escalating to all functions concerned
・Ensures that project startup targets site activation timelines and contract deliverables are met pro actively addresses risks and supports risk mitigation.
・Ensures accurate tracking of startup events in CTMS and other applicable system（s） for the study.
・Coordinate initiatives for startup process improvement analyze best practices and challenges
・Trains project teams in startup processes
・Mentors department staff in the country
・Supports the development and update of manuals local instructions and user guides relevant to startup activities within the Country/Region
・Participates in process improvement initiatives testing and implementation of new study startup practices

・College/University degree or an equivalent combination of education training and experience
・Prior study and site startup experience in Japan
・Full working proficiency in English and Japanese
・Communication and organizational skills
・Ability to negotiate and build relationships at all levels