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 DescriptionTake 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
- 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.
Skills Required
- College/University degree or 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
What We Do
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com
