職務描述
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.
需求人數
1~2人
學歷要求
碩士以上
科系要求
醫學系相關、醫學技術及檢驗相關、藥學相關
上班時段
日班
休假制度
依公司規定
工作技能
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
職務類別
Project Management Supervisor
Biotechnology Research and Development Staff
Pharmaceutical Research and Development Staff