Study Startup Specialist II (~Senior level)

Benefits

Additional Information

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 based in Tokyo or Osaka 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 Proficiency in Japanese and English language Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success. PSI is an inclusive and equal opportunity employer and is committed to attracting and retaining a diverse workforce that reflects the community we serve.

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