募集要項
- 募集背景
- An opportunity has arisen for a talented clinical researcher to join an international biopharmaceutical company as the Associate Clinical Operations Manager. In this role, you will have the opportunity to support clinical studies using your expert knowledge of regulations and therapeutic indicators.
- 仕事内容
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【Salary Negotiable】Responsibilities:
* Support the implementation and monitoring of clinical studies conducted within the country
* Manage up to 6 SCRAs responsible for site identification, qualification, initiation, interim monitoring and study close-out visits for phase 1-4 studies
* Support the provision of ongoing assessments of resource needs and allocate resources in alignment with the company's research goals, priorities and specific study timelines; identify and communicate issues that impact resource allocation and provide solutions
* Ensure clinical monitoring activities are conducted according to the monitoring plan and are in accordance with project timelines and company objectives
* Conduct all clinical site monitoring activities according to the monitoring plan and in accordance with study timelines
Requirements:
* Bachelor's degree
* 5+ years' clinical experience with 2 years as the clinical research monitor
* Expert knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials
* Expert knowledge of regulations governing clinical research, ICH/GCP guidelines and applicable regulations
* Strong written and verbal communication skills; strong English skills
* Japanese fluency
* Permission to work in Japan
- 応募資格
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- 必須
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5+ years' clinical experience with 2 years as the clinical research monitor
Expert knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials
- 雇用形態
- Permanent
- 勤務地
- Osaka
- 年収・給与
- Negotiable based on experience
