安成生物科技股份有限公司
臨床研究處 Clinical Trial Manager
10/4 Updated
Array
English Required
Full-time
Manager/Director
English RequiredSalary & Location
Salary negotiable
(Regular monthly salary of NT$40,000 or above)
台北市內湖區
Required
Language Requirements
English
聽/精通、說/精通、讀/精通、寫/精通
Work Experience
5年以上
Job Description
1. Oversee the clinical study quality to ensure GCP compliance.
2. Plan and execute the co-monitoring activities
3. Perform the periodical QC review of Trial Master Files.
4. Develop and manage the study budget and timeline.
5. Preform the CRO selection and supervision.
6. Negotiate the site/CRO/vendor budget and contract terms.
7. Plan and execute the recruitment activities to boost site enrollment rate.
8. Organize regular/ad-hoc study meetings.
9. Organize Investigator meeting as needed.
10. Lead the preparation and review of protocol, ICF, subject materials.
11. Develop study-specific plans, instructions, manuals, and/or templates.
Number of Openings
1~2人
Educational Requirements
碩士以上
Field of Study Requirements
醫學系相關、醫學技術及檢驗相關、藥學相關
Work Schedule
日班
Leave Policy
依公司規定
Job Skills
Project communication/integration management
Project management structure and project documentation
New Drug Research and Experiment Planning and Execution
專案溝通╱整合管理 專案管理架構及專案說明 新藥研發實驗規劃執行
Job Category
Project Management Supervisor
Biotechnology Research and Development Staff
Pharmaceutical Research and Development Staff
台北市內湖區
藥品製造業
安成生物科技股份有限公司總部位於台灣台北市研發治療罕見疾病的新藥研發公司，策略係以重新定位(Drug Reposition)已在臨床使用的藥物分子，滿足目前尚未有良好醫藥或新興醫藥的需求，尤其是以嚴重及無藥物可治療的罕見疾病為主要標的。我們以高效率創新，提供安全有效的新藥予全世界有迫切需要之病人為目標。
