南京 [切换城市] 南京招聘南京生物/制药/医疗器械招聘南京生物工程/生物制药招聘

Ass Manager/Manager, Study Manager/临床研究经理

缔脉生物医药科技(上海)有限公司

  • 公司规模:1000-5000人
  • 公司性质:外资(非欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2020-12-15
  • 工作地点:北京-朝阳区
  • 招聘人数:若干人
  • 工作经验:5-7年经验
  • 学历要求:本科
  • 语言要求:英语良好
  • 职位月薪:1.5-2.5万/月
  • 职位类别:生物工程/生物制药  临床研究员

职位描述

Position Summary 

Responsible for simultaneous delivery of the operational aspects of single/multi-center clinical studiesfrom protocol development 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 Study 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 Associate Study Manger or Study Manager or Senior Study Manager will reflect their level of experience and contribution that they can make to the project.   


Key Responsibilities 

Across Entire Study 

1. 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.

2. Actively manage the activities and deliverables of sponsor and all study partners (Investigator dMed Internal Use HR01-SOP-TP01, Effective 03-Mar-2017 Page 2 of 6 sites, site management functional lines, clinical supply, sub-contractors) to ensure timely delivery of quality data on specific studies.

3. Oversee site management functional lines to ensure that protocol and monitoring plan are consistently and appropriately implemented across clinical sites.

4. 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. 

5. 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.  


Study Start-Up


  • Protocol Development (if applicable)

1. Provide input to the protocol to ensure operational feasibility.  

2. 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. 

3. Produces study level ICD, as appropriate. 



  • Study budget 

1. Provide input to generation of a study budget plan provided to the client. 

2. Review and control clinical trial budget within scope of budget plan.



  • Data Management and Programming Interactions 

1. 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. 

2. 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.).



  • Site Selection and Start-up 

1. Oversee site selection progress and ensure appropriate site selection. 

2. 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). 



  • Training and Investigator Meeting (as needed) 

1. 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.  

2. Drive and/or contribute to investigator meeting strategy/agenda review meeting materials, facilitate and present at investigator meeting as required by sponsor.



  • Clinical Supply 

1. Collaborate with sponsor supply line to develop and complete of the Request for Clinical Supplies. 

2. Work with sponsor’s supply line to ensure that clinical trial drug supplies are ordered, produced, labeled and supplied in a timely manner. 


Clinical Study Conduct 

  • Subject Recruitment/Retention 

1. 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.  



  • Quality & Compliance Management

1. Periodically review protocol deviations and collaborate with clinicians to manage protocol deviations according to dMed SOPs. 

2. Proactively identify issues and take CAPA in a timely manner. Escalate findings and action plans to appropriate parties and ensure the sufficient documentation.  

3. Work with the internal quality control, internal / external Quality Assurance and site to ensure high quality of trial. 



  • Clinical Study Close-out  

1. 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. 

2. Accountable for study close out; support Data Management function in database lock and release activities, ensuring all timelines and quality goals are met.


Professional Experience & Education Requirement 

1. Minimum Medical or pharmaceutical education background or other life science degrees (or equivalent); experience in clinic practice is preferred.

2. 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 study manager.

3. Good working knowledge of GCP guidelines and good sense to regulatory requirements.

4. Broad knowledge of drug development process, and good relationship with investigators.

5. For a Senior Study Manager, shall possess the mature capabilities of Study 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.


Key Competency Requirement

1. Self-awareness and self-motivated.

2. Well-developed of communication (Chinese & English), presentation, and interpersonal skills.

3. Demonstrate thought leadership and innovative approach contributing to project outcome.

4. Facilitation and influence skills with multiple parties involved.

5. Strong problem solving and consultation skills Resilient in changing business environment, and able to drive and implement changes effectively and positively.



备注:职位月薪仅供参考,具体薪资和福利将根据候选人经验和能力综合评定。



公司介绍

全球知名生物医药企业资深研发团队打造的创新服务公司。让你的职场起点更高,更充满挑战和精彩。
 
我们是谁?
 
    基于中国面向全球制药,生物技术和医疗器械公司的临床开发服务和解决方案提供商:
· 临床试验全程及专业领域服务:临床试验设计、数据管理及系统开发、生物统计及编程、运营和项目管理、报告撰写、注册运作和策略、质量保证和稽查、药物安全警戒和风险管理
· 战略咨询服务:临床开发和注册策略、研发功能和架构设计、技术支持和国际化支持。
 
为什么选择我们?
 
· 缔脉定位于以高品质服务和专业精神成为业界典范。
· 缔脉管理层在中国生物医药研发领域耕耘十多年培养了1000+优秀人才。
· 缔脉致力于通过系统培训,研发实践和开放式文化培养新一代生物药物研发国际化人才。
 
创始人及部分核心专业领域


创始人 - 谭凌实博士:拥有20多年跨国一流制药公司总部高级管理经验。此前担任辉瑞公司全球药物开发运营副总裁,在中国成功创建了首屈一指的研发中心,且经历10多年发展壮大到多个地点,成为辉瑞全球核心的研发中心之一,承担药物临床开发、安全风险管理、注册、临床稽查等关键职能。谭博士多年为RDPAD, DIA 的核心成员,担任重要职务,包括研发委员会主席, 全球董事等。谭博士还带头建立了与国内一流高校的教育培训合作,比如复旦大学、北京大学,交通大学。培养了不少拥有专业技能和行业知识的临床数据管理和编程人才。谭博士有在美国建立初创企业的经验,且在美国一流制药企业研发中心工作多年。谭博士拥有生物统计博士学位。

联系方式

  • 公司地址:上海市浦东新区祥科路298号佑越国际,3楼301-305 (邮编:201203)
  • 电话:13552336942