任職要求:
1、醫(yī)/藥/護相關(guān)專業(yè),本科及以上學(xué)歷;
2、至少5年臨床試驗研究相關(guān)經(jīng)驗,其中包含至少2年以上的項目管理經(jīng)驗;
3、有國際多中心項目管理或腫瘤項目管理經(jīng)驗者優(yōu)先考慮;
4、英語六級,能獨立解讀英文方案,英語能作為工作語言;
5、具有良好的團隊服務(wù)和客戶服務(wù)意識,能獨立競標及短期出差。
1.Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.
2. Responsible for the overall project planning and execution of the project timeline, budget, scope,and quality regarding the assigned projects. Ensure accurate and timely communication with customers regarding delivery of work product and project progress.
3. Responsible for the trial documents filing and all operations complying with ICH, local regulation,SOPs and project plans.
4. Work with the line manager of the project team member to facilitate issue resolution and resource management.
5. Participate in the internal and external communication for issue identification / resolution andcustomer satisfaction. And ensure to follow the company SOP or project-specific QC processes forthe tasks coordination to solve the emerging issue/problem as necessary.
6.Responsible for participating and contributing to the BD project bidding and marketing activities,and to facilitate the success of business explore and contract award. Evaluate potential sites and provide recommendations for the selection of qualified sites.
7.Serve as CRC to conduct all jobs in compliance with Site management plan, ICH-GCP, SOPs, local regulations, and other applicable project-specific plans.
8. Assist in project quality management by accompanying CRCs during subject visits based on the requirements defined in the project-specific plan.
9.Take on additional responsibilities that may be assigned by the line manager.