募集要項
- 募集背景
- A multinational drug development services company is searching for an experienced clinical researcher to lead their clinical team in Japan as the Clinical Team Lead. This is an excellent opportunity to make full use of your bilingual Japanese/English ability and take the next step in your career.
- 仕事内容
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Responsibilities:
* Manage the clinical operations team with particular emphasis on teamwork, quality and compliance with the project plans
* Manage the clinical operations budget for the project; ensure that clinical operations activities are within budget and scope
* Take responsibility for managing the clinical operations timelines as agreed with the client
* Own and implement the risk and contingency plans for key clinical operations activities
Requirements:
* Bachelor's degree
* 5+ years' relevant clinical research experience
* Comprehensive understanding of ICH/GCP guidelines, Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs, site monitoring and study site management requirements
* Bilingual Japanese/English ability (native Japanese/advanced English or native English/intermediate Japanese)
- 応募資格
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- 必須
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・Bachelor's degree
・5+ years' relevant clinical research experience
・Comprehensive understanding of ICH/GCP guidelines, Serious Adverse Event (SAE) reporting, process production of reports, narratives
- 雇用形態
- Permanent
- 勤務地
- Osaka
- 年収・給与
- Negotiable based on experience
