Study Startup Lead (Tokyo or Osaka) at PSI CRO

Tokyo, , Japan -

Full Time

Start Date

Immediate

Expiry Date

24 Sep, 26

Salary

0.0

Posted On

26 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Study Startup, Site Identification, Site Selection, Project Management, Contract Negotiation, Budget Negotiation, Regulatory Submission, CTMS, Clinical Trial Management, Mentoring, Process Improvement, English Proficiency, Japanese Proficiency, Communication Skills, Organizational Skills, Relationship Building

Industry

Pharmaceutical Manufacturing

Description

Company Description We 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 1,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. Job Description 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. Hybrid workstyle (Tokyo or Osaka office) 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 Qualifications 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 Additional Information 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.

Responsibilities

Lead study startup activities and processes in Japan, providing operational support from project start to site activation. This includes managing site contracts, budgets, regulatory submissions, and mentoring department staff.