工作內容
We are looking for a Clinical Project Manager with excellent English communication for clinical trial management.
General Statement:
Responsible for the overall operational planning and activities for the implementation and conduct of clinical studies in accordance with prevailing laws and ICH GCP within established timelines and budgets.
Reports to: Chief Operating Officer
Primary Duties and Responsibilities, including mental requirements of position:
1. Plan, execute, oversight, and manage the clinical trials
2. Plan budget and control cost of the clinical trials
3. Manage and oversight vendors to ensure the achievement of various clinical trial milestones
4. Timely report clinical trial progress to internal project team and stakeholders
5. Proactively identify challenges or quality issues in the execution of clinical trials
6. Develop good relationship and maintain frequent contact with investigators and site staff
7. Conduct co-monitoring visits at clinical sites as necessary
8. Perform clinical data review of tables, figures and listings
9. Assist in reviewing AEs/SAEs and annual safety reports
10. Assist in reviewing Clinical Study Report
11. Provide clinical trial expertise in support of other departments and line functions
12. Assist in the development and maintenance of work instructions for clinical operations department
工作說明
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工作縣市:臺北市
- 上班地點:台北市信義區
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工作待遇:面議
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上班時段:日班,
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需求人數:1
條件要求
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工作經歷:
5年以上
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學歷要求:碩士
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科系要求:
醫藥衛生學科類
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專長需求:
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擅長工具:
- 具備駕照:
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其他條件:
Experience, education, or skills required of the incumbent in this position:
1. Master's degree or equivalent in the life sciences
2. At least 3 years working experience in all operational aspects of planning and executing clinical studies with 2 years project management experience
3. Motivated self-starter and discipline to work independently with minimal guidance
4. Excellent communication and interpersonal skills
5. Strong negotiation and presentation skills
6. Proficiency in written and spoken English and Mandarin
7. Ability to travel and work flexible hours