- Applicants must have permission to work in Japan
- Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)
☑Foreign business ☑English language required ☑Japanese language required
Senior Clinical Research Associate (Sr. CRA)
Global Pharmaceutical Company
- Performing selection, initiation, interim monitoring and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).
- Driving performance at the sites. Proactively identifying and ensuring timely resolution to study-related issues and escalates them as appropriate.
- Training, supporting and advising Investigators and site staff in study related matters, including Risk Based Quality Management (RBQM) principles.
- Development of recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones. Document recruitment barriers and mitigation plans.
- Ensure agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (Action Items aging, SDV metrics, Data entry metrics, query aging, MV reports metrics, etc.)
- English Language level: Business level
- Minimum of 4 years of CRA monitoring experience
- Bachelor's degree in related discipline, preferably in life science, or equivalent qualification
- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
- Excellent knowledge of relevant local regulations.
- Good medical knowledge and ability to learn relevant Therapeutic Areas.
- Good understanding of the drug development process.
- Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management.
- Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70% during busy periods)
Preferred skills and experience:
- Ability to work in an environment of remote collaborators and in a matrix reporting structure
- Experience in all study phases and in rare medical conditions preferred.
7 million yen - 9 million yen (Experiences and skills will be considered)
- Full 2 holiday week system)
- National holidays
- New year's holiday
- Annual Leave
Application screening and several interviews are scheduled.
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Seniority Level: Associate
Job Function: Research, Analyst, Quality Assurance