- 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
Clinical Trial Manager/ Senior Clinical Trial Manager - Early Phase
Global Pharmaceutical Company
The position is responsible for managing Japan portion of all phase 1-4 clinical trials for various therapeutic areas in partnership with global/regional clinical operations team and other functions under supervision of CPM/AD of Japan Clinical Operation.
- Provide a local expertise for development of Japan specific study timeline and managing clinical trial and meet timelines, milestones and regulatory requirements
- Develop RFPs, select CROs/vendors for Japan portion
- In partnership with Global Clinical Operations, oversee CRO for ensuring study quality by confirming update from CRO, conducting co-monitoring visits, TMF and assisting with the resolution of specific operational issues
- Provide guidance and training to CROs, venders, investigators and study coordinators on study
- Prepare and/or review the relevant parts of any regulatory documents including translated ones for clinical trial archive documents appropriately
- Establish good relationship with investigators and manage them to accelerate the development
- Oversee study sites/investigators and CRO, by reviewing source data and regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, Monitoring Plan and TMF plan as required
- Contribute to process standardization, develop /maintain local SOPs in Japan
- Prepare and maintain the Post Marketing Surveillance(PMS) and Post Marketing Clinical Trial(PMCT) collaborating with Late Phase team, if needed
- Participates in local, departmental, interdepartmental or strategic initiatives
- Experiences in clinical operation for 7-10 years (core member of the study team or lead clinical trials, if any)
- Experiences in clinical development and/or project management for at least 3 years, if any
- Experiences in oversight of CROs and vendors
- Experiences in source data verification (also PMDA inspection of clinical trial, if any)
- Experiences in managing KOLs, if any
- Through knowledge and understanding of Japanese Regulations, ICH Guidelines and GCPs governing the conduct of clinical trials is required
- Must have demonstrated capability to manage multiple tasks simultaneously, plan proactively and accomplish goals using well-defined instructions and procedures
- Good skills of communication in Japanese and English (such as >750 TOEIC, but equivalent English level is acceptable)
- Hands-on involvement is a must (effective use of external resources)
- International and domestic Travel is required
8.5 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: Science, Project Management, Research