1.

Pre-trial

technical management（临床前技术管理）:
1.1 Ensure the drug is manufactured

according to CMC document.
保证临床试验药品按照药学研究技术进行临床试验样品准备
1.2 Ensure investigational product is adapt

to protocol design.
保证临床试验样品适应临床试验方案的设计
2.

Clinical

trial management（临床试验管理）:
2.1 Be responsible for communication with

RA and CMC, to identify clinical relevant risk. Deliver clinical technical

support, identify potential risk during development strategies at feasibility

stage.
负责与注册部和制剂部的沟通，明确注册策略，识别临床试验相关的风险。在项目可行性分析阶段，提供临床试验的技术支持，确认和规避开发策略中潜在的风险
2.2 To support business development

department, to identify new commercial opportunities and developing

relationships as well as successfully managing existing client relationships

in vision of clinical trial development.
支持业务拓展部门鉴别新的商务发展机会，从临床试验开发角度，管理并与既有客户拓展关系
2.3 Be responsible for making/updating of

clinical trial plan including timeline of key activities as well as risk

management plan.
负责制定和更新包含关键项目时间点的临床试验计划以及风险管理计划
To provide draft timeline and cost

estimation based on assumption when initiate for Strategy Plan.
在项目计划初期，负责估算时间和费用
To develop study timeline, budget plan and

risk management plan once protocol synopsis ready.
临床试验摘要形成时，负责项目时间、预算以及风险管理计划的制定
To update study plan based on progress and

obtain management approval if applicable.
在临床实验过程中，调整临床试验进展。
2.4 To be responsible for screening,

assessment, confirmation and management of CRO; Be responsible for Quality

Control of CRO delivering
负责CRO公司的筛选、评估、确认以及管理，并对CRO的工作质量负责
To draft Request of Proposal and obtain

functional team’s confirmation.
准备标书并获得团队的确认
To initiate, coordinate the process of

quotation, assessment and final selection of CROs for responsible study refer

to local and global requirements.
按照本国和国际项目的要求启动并协调竞标过程，评估并完成CRO的筛选
2.5 To be key contact of CRO for

conducting the clinical trial from kick-off meeting to the following up

activities done by end of contract.
在临床试验操作过程中，自研究启动到合同结束，作为CRO的联系人
To confirm the lead PI’s selection internally

and obtain approval as well as the proposed qualified study site lists.
确定组长单位及参加单位的选择并获得内部批准
To review feasibility survey reports and

make reasonable recruitment plan along with CRO.
与CRO一起完成可行性调查，并完成合理的招募计划
To review and ensure internal approval of

all related documents (study plan, guideline and manuals etc.) drafted by

CROs.
审阅并确保全部CRO提供的临床试验文件的批准（包括临床试验计划、指南、手册等）
To review progress report, monitoring

visit report, QC report and QA report.
审阅临床试验进展报告，监查报告，质控报告以及稽查报告
To manage/resolve study related issues

reported by CRAs and other study team members.
管理和解决CRA和其他研究人员报告的研究相关问题
To contact vendors about trial supply,

document printing, data management, statistics and medical writing etc
与服务商联系，对临床试验物资、文件、数据、统计、医学写作等进行管理
To organize(or coordinate with CRO)

investigator meetings
与CRO公司一起组织研究者会议
To provide on-site and in-house study

specific training.
为中心和内部提供相应的项目培训
To develop and maintain good and effective

communication between clinical research staff.
与研究团队间建立并维持有效的沟通方案
To conduct site visits oversight，according to Protocol, ICH-GCP, laws, regulations and

SOPs
按照方案、GCP、法律、法规、以及SOP的要求，完成中心访视的整体监督
2.6 Be responsible for budget plan,

control and management in tracking systems or tools.
负责对项目预算，通过跟踪表格或其他工具，进行计划，控制和管理
To set up the budget plan based on

protocol.
按照临床试验方案制定预算
To ensure all items of budget plan tracked

in systems or tools.
确保各项预算按照预定计划使用
To ensure all payments tracked in system

and on target of budget plan.
确保所有花费均按计划支付
To ensure the periodic updates completed

on schedule.
定期更新完成预算时间表
2.7 Be responsible coordination of key

documents of development and finalization of clinical trial documents (includ

but not limit the protocol, ICF, CRF, DMP, SAP and CSR etc.)
负责关键文件（方案、知情同意书、病例报告表、数据管理计划、统计计划、临床试验报告）的撰写的协调和审核
To develop study protocol/amendment and

other project documents in cooperation with medical writer or other functional

manager.
负责并与医学支持或其他部门经理合作，进行临床试验方案和其他文件的设计
To provide inputs for study

protocol/amendment from clinical operation view.
从临床试验操作角度为完善临床试验方案
To maintain the Central Project File and

review the Sponsor Study Files to ensure the study files are completed well.
维护申办方中心文件，审核并确保项目文件的完整
2.8 Be responsible for preparation,

conduction and progress reporting
负责临床试验准备、操作、以及进行过程的报告
To co-work with clinical supplier for

study supply ordering and IVRS system setting and running.
与药品供应负责人合作进行药品订单在IRT系统的设置和运行
To coordinate and drive plans development,

including and not limited to PMP, SMP, DMP, SAP, MRP, and so on, by working

cross function.
组织多部门合作和推动项目管理所需要的 项目管理计划、安全管理计划、数据管理计划、统计分析计划、医学职责计划
To coordinate with Legal and Finance for

all contracts review and approval.
与法务及财务部门合作确保全部合同的审阅和批准
To coordinate with Finance Team to obtain

the Insurance of clinical trial before study start.
与财务部门合作，在试验开展之前，获得临床试验保险
To have periodic review of progress report

provided by CRO
定期审阅CRO公司提供的临床试验进展报告
To provide periodic progress reports to

management team as required.
定期按照要求向上级报告临床试验进展
To coordinate Investigator meeting along

with Medical Writer or CROs for protocol development or initiation.
在试验方案的制定过程中与医学支持一同协调组织研究者会议
To identify and try to resolve any

issue/risk for conducting clinical trial and escalate accordingly.
确定并解决临床试验操作过程的问题和风险，并向上级报告
3.

Staff

management in project（项目团队管理）
Work as general manager and primary

Contact for internal and external staff and of project，Train and ensure all team members attended the Trial

are qualified, allocation of tasks and ensuring roles are clarified，responsible for Issue escalation and feedback to team

of outcome of escalation，endure the productivity & quality of

trial of team，Evaluate team member with KPI, and

delivery of project/program successfully
作为临床试验的总的管理者和主要联系人，负责培训并保证内部外部团队人员的能力的合格性，清晰的分配临床试验任务，负责对临床研究团队反映的问题进行应答并提供解决方案，对团队效率、质量水平进行管理、并按照公司规定对员工在项目中的工作绩效的设定标准、并进行评估，各个职能均能够按照要求完成临床试验。
1.

教育背景和相关经验/ Education & Experience
a)

Degree/academic

background in life science/healthcare is ideally required本科以上学历，临床医学、生命科学等相关专业
2.

技能和能力/ Skills & Capabilities
a)

Significant

experience, at least 7 years, in health industry is required.在健康领域至少有7年工作经验