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正社員
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製薬
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＊This role requires native level Japanese and Business English＊
＊日本語がネイティブレベルで英語が流暢に会話ができる方(両方必須)＊
Principal Clinical Trial Manager at a top-tier Global Biopharmaceutical company
Basic overview of the job:
- Oversees prediction, planning, progress of studies from protocol outlines to final CSR to Japan
- Develops and maintain study project plan covering all study related activities/timeline tracking and review regularly with study team
- Plans, implements and completes tasks related to IMP imputation, distribution and return –Vendor Management Plan, implement and complete tasks related to vendors (if any)
- Reviews all study conduct-related Japanese documents and lead their authorization within the company
Requirements:
- Deep knowledge of global clinical trials under GCP
- Proven operational expertise in planning, execution, and reporting of global clinical trials
- Experience/knowledge in specialty care area is highly preferred
- Ability to communicate in English on a business level
- Candidates from CRO are very much welcome
Some attractive points:
- Next-level CTM job w/ extensive responsibilities
- Work in a highly innovative environment
- Collaborate with global counterparts on a daily basis
- Be responsible for exciting products and significantly contribute to improving patients’ lives
