募集要項
- 仕事内容
-
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
etc.
- 応募資格
-
- 必須
-
• Experiences in oversight of CROs and vendors
• Through knowledge and understanding of Japanese Regulations, ICH Guidelines and GCPs governing the conduct of clinical trials is required
• Good skills of communication in Japanese and English (such as TOEIC 750+ or equivalent)
• Hands-on involvement is a must (effective use of external resources)
• International and domestic Travel is required
• Experiences in Oncology TA, preferable
• 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 least3 years, if any
• Experiences in source data verification (also PMDA inspection of clinical trial, if any)
• Experiences in managing KOLs, if any
- 雇用形態
- 正社員
- 勤務地
- 東京都
- 年収・給与
- 想定年収：850万円～1200万円程度（応相談）※ご経験・スキルに応じて検討します。
- 待遇・福利厚生
- Social insurance
- 休日休暇
- Full 2 holiday week system (Sat/Sun) national holidays, New year’s holiday, Annual Leave
