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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(duì)簡(jiǎn)單和小規(guī)模的臨床試驗(yàn)，全程負(fù)責(zé)指定項(xiàng)目的項(xiàng)目管理，包括從項(xiàng)目啟動(dòng)到項(xiàng)目結(jié)束全過(guò)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(shí)間和預(yù)算等方面符合合同及項(xiàng)目計(jì)劃。
Project Assessment and Initiation
項(xiàng)目評(píng)估和啟動(dòng)：
1. Review the Project contract exhibit to identify staff necessary for the project team.
審查項(xiàng)目合同，以確定項(xiàng)目團(tuán)隊(duì)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(qǐng)項(xiàng)目團(tuán)隊(duì)資源。
3. Call the initial team meeting to review the contract and develop project implementation and communication plans.
召開團(tuán)隊(duì)內(nèi)部會(huì)議，審查合同，制定項(xiàng)目實(shí)施和溝通計(jì)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(duì)成員提供或安排項(xiàng)目相關(guān)培訓(xùn)。
6. Prepare and update the Project Management Plan (PMP).
編制和更新項(xiàng)目管理計(jì)劃（PMP）。
7. Start the project.
啟動(dòng)項(xiàng)目。
Project Tracking
項(xiàng)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(huì)議記錄、外部和內(nèi)部通信、所有項(xiàng)目相關(guān)報(bào)告（包括監(jiān)查報(bào)告以及電話報(bào)告）、后續(xù)信函、差旅、差旅報(bào)告和項(xiàng)目費(fèi)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(xiàng)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(xiàng)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(xiàng)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(xiàng)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(xiàng)目會(huì)議，將職責(zé)和任務(wù)交給項(xiàng)目組成員，監(jiān)測(cè)每個(gè)項(xiàng)目任務(wù)的進(jìn)度，評(píng)估項(xiàng)目的總體狀況，特別注意以下事項(xiàng)：
8. Regulatory document collection and submission.
項(xiàng)目文件的收集和遞交；
9. Site start-up status.
中心啟動(dòng)狀態(tài)
10. Enrollment status.
入組狀態(tài)
11. Monitor visit reports.
監(jiān)查報(bào)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(xiàng)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(duì)成員在每個(gè)項(xiàng)目任務(wù)上花費(fèi)的資源和實(shí)際時(shí)間，以評(píng)估項(xiàng)目進(jìn)度和盈利能力。
17. Perform Co-monitoring visit, if necessary.
必要時(shí)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(duì)成員傳達(dá)工作范圍、時(shí)間線和項(xiàng)目目標(biāo)、技術(shù)信息以及整個(gè)項(xiàng)目中來(lái)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(duì)成員任何可能影響團(tuán)隊(duì)成員具體職責(zé)的項(xiàng)目相關(guān)問(wèn)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(bào)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(duì)成員培訓(xùn)水平或績(jī)效的任何需求或問(wèn)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(jī)效評(píng)估的需要，向直線經(jīng)理提供有關(guān)團(tuán)隊(duì)成員績(jī)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(shí)間表內(nèi)提供項(xiàng)目狀態(tài)輸入，以向管理層提供所需的資源報(bào)告、預(yù)測(cè)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(bào)告并提交給客戶。
8. Communicate project issues to Line manager.
與直線經(jīng)理溝通項(xiàng)目問(wèn)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(jìng)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(xiàng)目的報(bào)價(jià)、提案及競(jìng)標(biāo)資料的準(zhǔn)備，必要時(shí)參與項(xiàng)目競(jìng)標(biāo)會(huì)。
2. As a contact for a specific customer, support the project manager in dealing with customer relationship issues, if necessary.
必要時(shí)可以作為特定客戶的聯(lián)系人，支持項(xiàng)目經(jīng)理處理客戶關(guān)系方面的問(wèn)題。
9. Finish other work assigned by line manager.
完成直線經(jīng)理分配的其他工作。