工作職責(zé) (Responsibility): 1. 支持特定項目團隊建立TMF并確保所有的研究文件按照SOP進行歸檔,按照項目TMF管理計劃進行文件的。 QC Assist to set up TMF folder and ensure TMF archiving with company SOP,and perform the QC according to project specific TMF management plan. 2. 支持項目團隊的會議組織(臨床試驗相關(guān)的研究者會議,咨詢會議等),幫助部門組織團隊建設(shè)活動。 Assist the project meeting, IM, record the meeting and progress report etc, also support for the department TB. 3. 協(xié)助項目團隊進行所需倫理遞交文件的打印和準備。 Assist to contact with vendor for printing of EC documentation according to the scope of work and standard operating procedures . 4. 參與供應(yīng)商的管理,包括組織供應(yīng)商竟標(biāo),比價,合同簽署及在整個研究期間的維護。 Assist with vendor management ,such as organize meeting of bidding, contract signing and contract m maintenance etc. 5. 研究中項目經(jīng)理安排的其他相應(yīng)的任務(wù)。 May perform assigned administrative tasks by the project managers. 6. 協(xié)助試驗相關(guān)的文件翻譯。 Assist to contact with vendor for related clinical docs translation. 7. 為部門新員工提供入職支持。 Provide supporting for new onboarding staff. 8. 為項目建立相關(guān)的系統(tǒng)如AIS, CTMS等。 To set up the system for specific project, for example, AIS, CTMS. ? ? 任職要求 (Qualification): 1. 生命科學(xué)領(lǐng)域本科及以上。 Bachelor degree and above in the science area. 2. 熟練掌握MS-office。 Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint. 3. 英語和普通話流利(書面和口頭)。 Good written and verbal communication skills including good command of English language. 4. 良好的溝通能力,時間管理以及組織能力。 Effective communication ,time management and organizational skills.