长沙招聘

Position Summary: 职位概要

Responsible for large scale and complex clinical trials independently. 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. Establish and complete the project management team training materials, the working procedures and the standard of performance assessment. 根据合同和方案要求独立全程管理指定的较大规模和难度的临床试验的运行，全程负责指定项目的项目管理，包括从项目启动到项目结束全过程管理。确保所负责的所有临床研究相关工作是根据标准操作规程（SOP）、适用的法规要求、工作范围和客户的要求进行的，并在质量、时间和预算方面符合项目计划。 参与项目管理团队培训材料、工作流程和绩效考核标准的建立与完善。   

 Project Assessment and Initiation 项目评估和启动： 

 1.        Review the Project contract exhibit to identify staff necessary for the project team. 审查项目合同，以确定项目团队所需的人员。 

 2.        Request project team resources from the appropriate Line Manager(s) when a contract has been awarded. 合同授予后，向相关直线经理申请项目团队资源。 

 3.        Call the initial team meeting to review the contract and develop project implementation and communication plans. 召开团队内部会议，审查合同，制定项目实施和沟通计划。 

 4.        Ensure information entered into management systems is correct and complete. 确保输入管理体系的信息正确、完整。 

 5.        Provide or arrange for project-related training as needed for team members. 根据需要为团队成员提供或安排项目相关培训。 

 6.        Prepare and update the Project Management Plan (PMP). 编制和更新项目管理计划（PMP）。 

 7.        Start the project. 启动项目。   

 Project Tracking 项目跟踪： 

 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. 审查会议记录、外部和内部通信、所有项目相关报告（包括监查报告以及电话报告）、后续信函、差旅、差旅报告和项目费用。 

 2.        Assure the project is completed within budget, schedule, and according to contract specifications, managing precisely based on ERP/CTMS/eTMF system. 确保项目在预算、进度和合同规定的范围内完成，并准确使用ERP/CTMS/eTMF系统进行项目管理。 

 3.        Assure the project is progressing according to quality standards, SOPs, ICH and/or other guidelines to fulfill local regulations. 确保项目按照质量标准、标准操作规程、ICH和/或其他指南进行，以满足当地法规的要求。 

 4.        Determine the cause of project overruns, recommend and institute corrective action. 确定项目超支的原因，建议并采取纠正措施。 

 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: 定期召开项目会议，将职责和任务交给项目组成员，监测每个项目任务的进度，评估项目的总体状况，特别注意以下事项： 

 ？  Regulatory document collection and submission. 项目文件的收集和递交； 

 ？  Site start-up status. 中心启动状态； 

 ？  Enrollment status. 入组状态； 

 ？  Monitor visit reports. 监查报告； 

 ？  Site drug inventories. 中心药品管理； 

 ？  Serious Adverse Events (SAEs). 严重不良事件； 

 ？  Data entry status of CRFs . CRF的数据录入； 

 ？  Study close out 项目关闭。 

 6.        Track resources and actual time spent on each project task for all team members to evaluate project progress and profitability. 跟踪所有团队成员在每个项目任务上花费的资源和实际时间，以评估项目进度和盈利能力。 

 7.        Perform Co-monitoring visit, if necessary. 必要时进行协同监查访视。   

  Communications 沟通： 

 1.        Communicate to team members the scope of work, timeline and project goals, technical information, and input from clients throughout the project. 向团队成员传达工作范围、时间线和项目目标、技术信息以及整个项目中来自客户的其他研究相关信息。 

 2.        Inform team members of any new information or modification of project-related issues which may affect specific responsibilities of team members. 告知团队成员任何可能影响团队成员具体职责的项目相关问题的新信息或更新。 

 3.        Report to Line Managers any anticipated need for addition or re-assignment of resources. 向直线经理报告增加或重新分配资源的预期需要。 

 4.        Communicate to Line Manager any needs or concerns regarding level of training or performance of team members. 与直线经理沟通有关团队成员培训水平或绩效的任何需求或问题。 

 5.        Provide Line Manager with input regarding team members’ performance as needed for employees' periodic Performance Review. 根据员工定期绩效评估的需要，向直线经理提供有关团队成员绩效的信息。 

 6.        Provide project status input within the agreed monthly timeline to provide management with the required resource reports, forecasts and revenue recognition information. 在商定的每月时间表内提供项目状态输入，以向管理层提供所需的资源报告、预测和收入确认信息。 

 7.        Prepare Administrative Reports and submit to clients as required by the contract. 按合同要求完成进度管理报告并提交给客户。 

 8.        Communicate project issues to Line manager. 与直线经理沟通项目问题。   

 Others： 其他： 

 1.        Bidding Support: Support in the preparation of new project quotation, proposal and bidding materials, and participate in project bidding meeting when necessary. 竞标支持：协助进行新项目的报价、提案及竞标资料的准备，必要时参与项目竞标会。 

 2.        Provide guidance or help to less experienced employees according to the requirements of line manager, if necessary. 必要时，依据直线经理要求指导经验较少员工的工作或提供帮助。 

 3.        As the mentor of specific project according to the requirements of line manager, provide support for project quality management, guide project manage to find quality problems in the project, find solutions to problems, and implement rectification and preventive measures, if necessary. 必要时，依据直线经理要求作为特定项目的指导人，为项目的质量管理提供支持，指导项目经理发现项目中的质量问题，寻找问题的解决方案，实施整改及预防措施。 

 4.        May be assigned as the author or reviewer of standard operating procedures related to project management. 可能被分配担任项目管理相关标准操作流程的作者或者审阅者。 

 5.        Participate in the formulation, regular review and modification of standard operation process of project management department. 参与项目管理部门标准操作流程的制定、定期审阅和修改。 

 6.        Finish other work assigned by line manager. 完成直线经理分配的其他工作。 

 Knowledge, skills and capability 所需知识、技能和能力 

 1.       Abundant clinical research knowledge and skills, follow the updated regulatory and laws. 丰富的临床研究相关知识和技能,以及及时跟进法规更新，掌握相关法律知识。 

 2.       Deeply understand the therapeutic area and protocols. 深入了解治疗领域和研究方案方面的知识。 

 3.       Good at oral and verbal communication (including English) 良好的口头和书面沟通能力（包括能熟练应用英语）。 

 4.       Better team leadership, could guide and train the study team well 较好的团队领导能力，有效的指导和培训能力。 5.       Deliver the study by the established quality, finance and timeline plan 能够按照既定的质量、财务和时间计划完成任务的能力。 

 6.       Good at planning, organizing and issue solving 良好的计划、组织和解决问题的能力。 

 7.       Effective time management skills 有效的时间管理技巧。 

 8.       Good client service awareness and skills 良好的客户服务意识和技巧。 

 9.       Familiar with laptop and MS office including Word, Excel and PowerPoint 计算机技能，包括熟练应用Word、Excel和PowerPoint，以及熟练使用手提电脑。 

 10.   Establish and maintain the highly effective working relationship with colleagues, managers and clients 与同事、经理和客户建立和维护高效工作关系的能力。 

 11.   Consistently follow the SOPs requirement 能始终遵循SOP要求。 

 12.   The capability for independent thinking, supporting the procedure improvement 善于独立思考，为流程改进提供帮助。   

 Education and experience requirement 最低学历和经验要求

1.       BS degree in a clinical medical, pharmacology, nursing, health management or related medical majors 临床医学、药理学、护理学、卫生管理或其他医药相关专业的本科学历。 

 2.       7 years or above clinical trials experience, 3 year project management at least.七年以上临床研究经验，其中至少三年的项目管理经验。   

 Body requirement 身体要求 

 1.       Usually communicated by phone and F2F, precisely voice recognition needed. 需要经常使用电话和面对面沟通，要求准确的言语听辩。 

 2.       Fully functional fingers, need use keyboard 需要经常使用键盘，要求手指功能健全。 

 3.       Working at the desk for long time. 需要长时间伏案工作。 

 4.       Occasionally business travel 偶尔出差。