- 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
Manager, Regional Sponsor Oversight Lead
Global Pharmaceutical Company
As SOL at the Company you will be responsible for the planning, conducting and coordination of trial oversight activities together with internal and external stakeholders to ensure quality and integrity of the data especially Japan and APAC. The SOL works closely together with the Clinical Trial Managers with the oversight activities across the Company's clinical trials.
The responsibilities of the role will include, but are not limited to:
- Develop the Sponsor oversight strategy together with the trial team
- Plan and perform Sponsor oversight visits and booster/site oversight visits in Japan and APAC
- Accountable for development of trial oversight plan and ensure regular review of the trial team's oversight activities
- Feasibility review
- Support Regulatory Green Light activities
- Drive eTMF spot-check for the trial team and in collaboration with the CTM and CTA
- Oversight of CRO training records, monitoring report review etc.
- Attend and coordinate CRA training activities with CRO
- Support during inspections and audits
- Extensive knowledge of working with trial oversight activities is required.
- It is expected that you have a minimum 5+ years' experience with monitoring and/or co-monitoring of clinical trials (Oncology Phase I experience preferred).
- Preferably 5+ years' experience as Trial Manager from a CRO and/or pharmaceutical company.
- HA inspection preparation and responding experience preferred
- Ability to travel to field sites.
- Business level English (and native level Japanese, reading & writing).
8 million JPY - 12 million JPY (Experiences and skills will be considered)
Full 2 holiday week system (Sat/Sun), 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: Mid-Senior level
Job Function: Quality Assurance, Management, Strategy / Planning