Study Startup Specialist II

【求人No NJB2302347】
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.

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

College/University degree in Life Sciences or an equivalent combination of education training and experience
2 3 years prior clinical study and 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）