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Position Summary: 職位概要： Responsible for relatively simple and small size clinical trials according to the line manager guiding and supporting. Taking in charge with the whole project management from the study setup to the closeout. Making sure all the project activities are following the SOPs, applicable regulatory, work scope and clients’ requirements, meeting the demands of quality, timeline and budget request from contract and study. 在直線經(jīng)理的指導(dǎo)和支持下，根據(jù)合同和方案要求管理相對簡單和小規(guī)模的臨床試驗，全程負(fù)責(zé)指定項目的項目管理，包括從項目啟動到項目結(jié)束全過程管理。確保所負(fù)責(zé)的所有臨床研究相關(guān)工作是根據(jù)標(biāo)準(zhǔn)操作規(guī)程（SOP）、適用的法規(guī)要求、工作范圍和客戶的要求進(jìn)行的，并在質(zhì)量、時間和預(yù)算等方面符合合同及項目計劃。 Project Assessment and Initiation 項目評估和啟動： 1. Review the Project contract exhibit to identify staff necessary for the project team. 審查項目合同，以確定項目團(tuán)隊所需的人員。 2. Request project team resources from the appropriate Line Manager(s) when a contract has been awarded. 合同授予后，向相關(guān)直線經(jīng)理申請項目團(tuán)隊資源。 3. Call the initial team meeting to review the contract and develop project implementation and communication plans. 召開團(tuán)隊內(nèi)部會議，審查合同，制定項目實施和溝通計劃。 4. Ensure the company level management system inputs correct and completed.確保輸入公司各管理體系的信息正確、完整。 5. Provide or arrange for project-related training as needed for team members. 根據(jù)需要為團(tuán)隊成員提供或安排項目相關(guān)培訓(xùn)。 6. Prepare and update the Project Management Plan (PMP). 編制和更新項目管理計劃（PMP）。 7. Start the project. 啟動項目。 Project Tracking 項目跟蹤： 1. Review meeting minutes, external and internal correspondence, all project-related reports (including the study monitors’ site visit reports and telephone reports), follow-up letters, travel itinerary, trip reports, and project expenses. 審查會議記錄、外部和內(nèi)部通信、所有項目相關(guān)報告（包括監(jiān)查報告以及電話報告）、后續(xù)信函、差旅、差旅報告和項目費用 2. Assure the project is completed within budget, schedule, and according to contract specifications, managing precisely based on ERP/CTMS/eTMF system . 確保項目在預(yù)算、進(jìn)度和合同規(guī)定的范圍內(nèi)完成，并準(zhǔn)確使用ERP/CTMS/eTMF 系統(tǒng)進(jìn)行項目管理。 3. Assure the project is progressing according to quality standards, SOPs, ICH and/or other guidelines to fulfill local regulations. 確保項目按照質(zhì)量標(biāo)準(zhǔn)、標(biāo)準(zhǔn)操作規(guī)程、ICH 和/或其他指南進(jìn)行，以滿足當(dāng)?shù)胤ㄒ?guī)的要求。 4. Determine the cause of project overruns, recommend and institute corrective action. 確定項目超支的原因，建議并采取糾正措施。 5. Hold project meetings on a regular basis for delegation of responsibilities and tasks to project team members, monitoring the progress of each individual project task, and assessing the overall status of the project, with particular attention to the following: 定期召開項目會議，將職責(zé)和任務(wù)交給項目組成員，監(jiān)測每個項目任務(wù)的進(jìn)度，評估項目的總體狀況，特別注意以下事項： 8. Regulatory document collection and submission. 項目文件的收集和遞交； 9. Site start-up status. 中心啟動狀態(tài) 10. Enrollment status. 入組狀態(tài) 11. Monitor visit reports. 監(jiān)查報告 12. Site drug inventories. 中心藥品管理 13. Serious Adverse Events (SAEs). 嚴(yán)重不良事件 14. Data entry status of CRFs . CRF的數(shù)據(jù)錄入； 15. Study close out 項目關(guān)閉 16. Track resources and actual time spent on each project task for all team members to evaluate project progress and profitability. 跟蹤所有團(tuán)隊成員在每個項目任務(wù)上花費的資源和實際時間，以評估項目進(jìn)度和盈利能力。 17. Perform Co-monitoring visit, if necessary. 必要時進(jìn)行協(xié)同監(jiān)查訪視。 Communications 溝通： 1. Communicate to team members the scope of work, timeline and project goals, technical information, and input from clients throughout the project. 向團(tuán)隊成員傳達(dá)工作范圍、時間線和項目目標(biāo)、技術(shù)信息以及整個項目中來自客戶的其他研究相關(guān)信息。 2. Inform team members of any new information or modification of project-related issues which may affect specific responsibilities of team members. 告知團(tuán)隊成員任何可能影響團(tuán)隊成員具體職責(zé)的項目相關(guān)問題的新信息或更新。 3. Report to Line Managers any anticipated need for addition or re-assignment of resources. 向直線經(jīng)理報告增加或重新分配資源的預(yù)期需要。 4. Communicate to Line Manager any needs or concerns regarding level of training or performance of team members. 與直線經(jīng)理溝通有關(guān)團(tuán)隊成員培訓(xùn)水平或績效的任何需求或問題。 5. Provide Line Manager with input regarding team members’ performance as needed for employees' periodic Performance Review. 根據(jù)員工定期績效評估的需要，向直線經(jīng)理提供有關(guān)團(tuán)隊成員績效的信息。 6. Provide project status input within the agreed monthly timeline to provide management with the required resource reports, forecasts and revenue recognition information. 在商定的每月時間表內(nèi)提供項目狀態(tài)輸入，以向管理層提供所需的資源報告、預(yù)測和收入確認(rèn)信息。 7. Prepare Administrative Reports and submit to clients as required by the contract. 按合同要求完成進(jìn)度管理報告并提交給客戶。 8. Communicate project issues to Line manager. 與直線經(jīng)理溝通項目問題。 Others： 其他： 1. Bidding Support: Under support of Line manager, assist in the preparation of new project quotation, proposal and bidding materials, and participate in project bidding meeting when necessary. 競標(biāo)支持：在直線經(jīng)理的指導(dǎo)和支持下，協(xié)助進(jìn)行新項目的報價、提案及競標(biāo)資料的準(zhǔn)備，必要時參與項目競標(biāo)會。 2. As a contact for a specific customer, support the project manager in dealing with customer relationship issues, if necessary. 必要時可以作為特定客戶的聯(lián)系人，支持項目經(jīng)理處理客戶關(guān)系方面的問題。 9. Finish other work assigned by line manager. 完成直線經(jīng)理分配的其他工作。