English

Position Title:Project Manager/Sr Project Manager
Department:Project Management
Location:上海/北京/广州等城市

Position Summary

职位简介


Responsible for simultaneous delivery of the operational aspects of single/multi-center clinical studies from Study start up through study close out to ensure high quality, timely and cost effective conduct of the clinical trials. Ensure the study conduction in accordance with ICH-GCP, local regulatory requirements, and the Standard Operating Procedures (SOPs) of Sponsor and /or dMed. The Project manager also contributes to support effective study reporting; submission activities; and audits/inspections, as appropriate. He/she achieves this purpose by thoroughly understanding protocol and actively managing the activities and deliverables of all study conduct.

The degree of responsibility accorded to Project Manager or Senior Project Manager will reflect their level of experience and contribution that they can make to the project.

从研究方案制定到研究结束,项目管理经理负责单一中心或多中心临床研究运营各个方面的快速结果交付以确保临床试验的开展是高质、快速、优成本的。确保临床试验的实施遵从药物临床试验质量管理规范(ICH-GCP)、当地法规监管要求以及申办方和/或缔脉的标准操作规程(SOPs)。项目管理经理还需要有效地支持研究报告的完成和递交等相关工作,也要协助稽查和/或核查等。通过透彻的理解试验方案并在项目进行中主动管理各项事务和结果交付,从而达成研究的各项目标。

不同等级(项目管理经理/高级项目管理经理)的职位要求和责任是与相关经验和项目具体工作的贡献相匹配的。



Key Responsibilities

主要责任

Across Entire Study:

整个研究过程:

  • Manage overall project execution, progress, quality control and risk management. Keep good communications with sponsor and provide regular report on the study progress, and escalate the issue with action proposal when necessary
对负责的临床研究项目的执行,进展,质量控制和风险进行全面管理。与申办方保持良好的沟通,定期汇报项目进展,出现的问题和解决方案
  • Actively manage the activities and deliverables of sponsor and all study partners (Investigator sites, site management functional lines, clinical supply, sub-contractors) to ensure timely delivery of quality data on specific studies
积极管理临床研究中的各项流程,与申办方和所有研究合作方(研究中心、研究中心管理团队、临床供给、分包合同方等)共同协作,以确保高质量的研究数据及时交付
  • Effectively manage and lead project team to deliver key clinical operation milestones for serviced studies
高效管理和带领项目团队达成临床试验运营中各个关键的里程碑
  • Oversee site management functional lines to ensure that protocol and monitoring plan are consistently and appropriately implemented across clinical sites
监管研究中心管理团队以确保方案和监查计划能够一致统一地在研究中心执行
  • Proactively identify and resolve study operation-related issues as they arise
积极发现和解决项目运营中出现的问题
  • Develop study management plan to ensure the clinical study operations to meet the time, quality & cost targets consistent with the plan-reached agreement with sponsor
制定项目管理计划,确保临床研究在时间、质量和成本控制方面达成与申办方共同制定的目标
  • Ensure that the studies to be conducted in compliance with ICH-GCP, relevant SOPs, and local regulatory requirements; Responsible for inspection readiness for all aspects of the study conduct
确保临床研究的实施遵从药物临床试验质量管理规范(ICH-GCP)、国家法规监管要求以及申办方和/或缔脉的标准操作规程(SOPs)。负责确保研究实施的各个方面满足核查要求
  • Share best practices across the organization to ensure cross-line standardization
积极进行部门之间的经验分享以确保跨部门工作的标准化和一致性

Study Start-Up:

临床研究启动:


Protocol Development (if applicable)

研究方案(如适用)

  • Provide input to the protocol to ensure operational feasibility
在制定和执行方案的过程中提供建议以确保方案操作的可执行性
  • Responsible to guide or lead CRAs to conduct both protocol and site feasibilities within a required timeframe and provide input to the study management components of the protocol
在规定期限内指导或带领临床研究专员开展方案和研究中心的可行性分析,对方案中的研究管理部分提出合理建议
  • Produces study level ICD, as appropriate
拟定项目层面的知情同意书(如适用)

Study budget

项目预算

  • Provide input to generation of a study budget plan provided to the client
在为客户制定项目预算计划时提供意见
  • Review and control clinical trial budget within scope of budget plan
审核并控制研究项目的预算在计划范围内


Data Management and Programming Interactions

与数据管理和编程沟通

  • Support programing, data management to ensure set up of data capture tools (CRFs and EDC system, data management plan, diary cards, questionnaires, translations etc.) to ensure completion within project deliverable timelines
对数据管理和编程提供支持以确保数据采集工具(病例报告表、电子数据采集系统、数据管理计划、日记卡、调查表、翻译等)的建立在规定时间内完成
  • Overall responsible for ensuring the study has efficient and effective data flows (for all types of study data, including SAEs, endpoints, patient diaries, lab data, etc.)
确保有效的数据传输(各种试验数据包括严重不良事件、观察终点、病人日记、实验室数据等)

Site Selection and Start-up

研究中心的选择和启动

  • Oversee site selection progress and ensure appropriate site selection
管理研究中心选择的进展并确保选择合适的研究中心
  • Develop site start up plan and oversee site start up progress to ensure site readiness within planned timeline (Clinical Site Agreements, Ethics Committee approvals, HGRAC approvals and to meet other regulatory requirements, e.g. clinical registry)
制定中心启动计划并管理中心启动进程,确保中心在计划的时间内完成启动前的准备工作(包括临床研究合同的签署、伦理委员会批准、人类遗传资源管理委员会批准并满足其他监管法规要求如临床研究注册登记等)

Training and Investigator Meeting (as needed)

培训和研究者会议

  • Develop study Monitoring Plan; ensure CRAs, sites and the other relevant functional lines are trained on Protocol-Specific and the aspects of the Study Monitoring Plan.
制定研究监查计划书。确保临床研究专员、研究中心和其他相关人员完成试验方案和监查计划相关方面的培训
  • Drive and/or contribute to investigator meeting strategy/agenda review meeting materials, facilitate and present at investigator meeting as required by sponsor
负责和/或协助研究者会议的策略和日程,审阅会议材料,根据申办方要求参与研究者会的安排和相关主题的介绍
Clinical Supply
研究供给
  • Collaborate with sponsor supply line to develop and complete of the Request for Clinical Supplies
与申办方的供给部门合作,制定并完成临床研究供给的要求申请
  • Work with sponsor’s supply line to ensure that clinical trial drug supplies are ordered, produced, labeled and supplied in a timely manner
与申办方的供给部门合作,确保临床研究药物及时下单、生产、包装标签和供给


Clinical Study Conduct

临床研究执行


Subject Recruitment/Retention

受试者招募/保留

  • Develop and adjust study level subject recruitment/retention strategy or plan, oversee implementation of plan, take appropriate action to ensure targets are archived within timeline
制定和调整项目的受试者招募/保留策略或计划, 并在试验进行中对计划的执行进行管理并采取相应的措施以确保按期达成受试者目标数


Quality & Compliance Management

质量和依从性管理

  • Periodically review protocol deviations and collaborate with clinicians to manage protocol deviations according to dMed SOPs.
定期审核方案违背情况,按照缔脉标准操作流程的要求与临床研究医生合作,对这些违背案例进行管理
  • Proactively identify issues and take CAPA in a timely manner. Escalate findings and action plans to appropriate parties and ensure the sufficient documentation.
积极发现问题并及时采取修正和预防性措施,将发现问题和采取的措施及时和相关人员进行反馈沟通并确保完整的文档记录
  • Work with the internal quality control, internal / external Quality Assurance and site to ensure high quality of trial. Coordinate with site audit or inspection) if any and ensure the CAPA completion with the required timeframe.
与内外部的质量控制人员、稽查人员、研究中心合作以保证试验的高质量。协助研究中心的稽查和核查确保修正和预防性措施在规定时限内完成


Other related activities

其它相关活动

  • Ensure the drug supply (including resupply) process timelines, risks and issues are handled in a timely manner. Ensure investigational drug management at site to meet the requirements per protocol.
确保研究药物按计划供应(包括后续供应),及时解决相关的风险和问题。确保研究药物在中心的管理满足方案的要求
  • Work closely with the data management function to ensure data entry, query resolution at the protocol level. Take actions to ensure the milestone of data management, data entry, data cut-off, interim analysis, data cleaning, database lock
与数据管理部门合作,确保数据录入、疑问的解决。采取措施确保数据管理、录入、数据截止、中期分析、数据清理、数据库锁定等里程碑按期完成
  • Vendor management and oversight if any sub-contractor is involved.
如涉及到分包合同,负责相应的合同方管理和监督
  • Well manage and control the study budget, and keep communication with sponsor if the budget needed to be adjusted
管理控制项目预算,如果需要调整及时与申办方沟通

Clinical Study Close-out

临床研究结束


  • In close partnership with the sites and site management functional lines to ensure site closeout activities including the self-assessment per regulatory requirements are completed
与研究中心以及中心管理部门合作,确保中心关闭的各项工作及时完成(包括依照法规要求进行的自查)
  • Accountable for study close out; support Data Management function in database lock and release activities, ensuring all timelines and quality goals are met
负责研究结束流程,支持数据管理部门数据库关库,确保项目时间表和质量目标的达成。

Education and Key Competency Requirements

教育和能力要求

Professional Experience & Education Requirement

专业经验与教育要求

  • Minimum Medical or pharmaceutical education background or other life science degrees (or equivalent); experience in clinic practice is preferred
医学或者医药教育背景或生命科学专业学位,有临床经验者优先
  • Minimum 3-5 years of experience in clinical trials as CRA, including at least 1 year involved in project management or equivalent, and present excellent performance and good potential to be a Project manager
至少3-5年临床研究专员的经验,包括至少1年项目管理或相关工作经验,以及优良的绩效表现和成为项目经理的潜力
  • Good working knowledge of GCP guidelines and good sense to regulatory requirements
熟悉对药物临床试验质量管理规范,良好的法规要求意识
  • Proficiency in Basic Microsoft Word and Excel and familiarity with use of database
精通基本的办公自动化软件和数据库的使用
  • Broad knowledge of drug development process, and good relationship with investigators
丰富的临床开发流程知识,与研究者有良好的工作关系
  • For a Senior Project Manager, shall possess the mature capabilities of Project Manager. Capable and experienced in handling complex or difficult situations or projects to meet study goal. Has profound knowledge and capability to mentor or coach to junior & new members
高级项目管理经理能够处理更加复杂的问题,在棘手的环境中处理得当从而满足项目目标。同时具有深厚的知识和能力以辅导和培训新成员

Key Competency Requirement

主要能力要求


  • Organizational commitment and result Oriented
有组织意识,注重结果
  • Self-awareness and self-motivated
良好的自我认识和自我驱动能力
  • Well-developed of communication (Chinese & English), presentation, and interpersonal skills
良好的中英文沟通能力,演讲能力和良好的人际沟通技巧
  • Teamwork and collaborative working attitude
团队协作力强
  • Demonstrate thought leadership and innovative approach contributing to project outcome
具备领导能力和创新意识从而交付结果
  • Facilitation and influence skills with multiple parties involved
多方介入时有协调和影响能力
  • Project leadership and management skills with proven record; Capable to plan and prioritize to manage competing objectives
有书面记录证明其具备项目领导和管理能力,工作有计划性并能就轻重缓急合理安排
  • Strong problem solving and consultation skills Resilient in changing business environment, and able to drive and implement changes effectively and positively
面对不断变化的项目需求,能够主动灵活地处理和解决问题,能够有效地、正面地推动和实施变化应对措施



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