Data Management，Associate Manager 北京

月薪： 20-30万/年

该公司所有职位
  • 无工作经验
  • 招若干人
  • 11-09 发布

职位描述

职位描述： This is a professional individual contributor role that provides a study level data management CRO oversight and takes data management accountability for one or more low to moderate complexity trials. Makes recommendations and influences decisions to trial processes in line with business needs and in support of Clinical Development and Medical Affaires clinical studies. Looks over DM CRO project timelines and ensures quality of DM deliverables by CRO DM. Oversees E2E processes for China MAF trials. Consults with internal clients on DM issues in trial set-up, trial conduct and database lock activities. Facilitates real-time inspection readiness of all China DM deliverables for clinical trial and works on archiving documents for trials. Participates in process, system and tool improvement initiatives within China DM and presents at investigator and monitor meetings if assigned. Works with Data Management Leader to facilitate compliance with regulatory guidelines.Principal accountability and internal and external contacts:Provides data management CRO oversight and takes data management accountability for one or more low to moderate complexity trials. Facilitates real-time inspection readiness of all China DM deliverables for clinical trial and works on archiving documents for trials.Makes recommendations and influences decisions to trial processes in line with business needs and in support of Clinical Development and Medical Affaires clinical studies. Looks over DM CRO project timelines and ensure quality of DM deliverables by CRF DM. Oversees E2E processes for China MAF trials.Participates in process, system and tool improvement initiatives within China DM and presents at investigator and monitor meetings if assigned.Works with Data Management Leader to facilitate compliance with regulatory guidelines. Consults with internal clients on DM issues in trial set-up, trial conduct and database lock activities.IV. Qualification and competency requirements：A. Education /Training background:Bachelor/Master or above degree in a scientific discipline or health related field.B. Knowledge/Skills:Full understanding of relevant regulatory guidelines, GCP and international guidelines regarding data management Understanding of the clinical drug development process in the pharmaceutical industryExperience with DM systems e.g. Medidata Rave, ClinTrial？, InForm？Understanding of current industry standards (CDISC, SDTM, CDASH...) and of technology platforms for data exchange.C. Job experience:Requires ＞= 6 years of experience in data management and in clinical drug development in the pharmaceutical industry.D. Competency:Diligent and serious, precise thinking, strong sense of responsibility and accountability. Results and performance driven, sense of urgency. Team spirit, attention to details and good self-awareness.E. Others:Good written and great verbal communication skills in Chinese and English. Being able to give presentations and actively participate in meetings in both Chinese and English.V. Key achievement measurements：Quality of study data for clinical studies.Smoothness of trial conduct and database lock in terms of data management deliverables.Great collaboration with internal and external stakeholders.Independency and willingness to teach, support and lead colleagues and stakeholders.VI. Major challenge (mainly future 24 months):Build experience and expertise in overseeing external DM vendors with different processes and DM systems. Balance between global standards requirements and local practice.Learn and prepare to become an expert in non-trial related domain(s)/process (es) and taking responsibility when assigned for it.Show flexibility in support of colleague data managers in peak work load periods and learn to prioritize.Learn to see the bigger picture of data management in the end to end drug development process.Take a leadership role for job responsibilities and seek guidance only when required. Sharelessons learned with China DM colleagues or share new ways of doing work more effectively. 职能类别： 生物工程/生物制药

联系方式

北京市朝阳区建国路77号华贸中心写字楼

公司信息

公司简介(中文) 恢复为 “成立于1985年的西安杨森制药有限公司（“西安杨森”）是中国最大的合资制药企业之一，也是中国改革开放以来进入中国的最早一批制药公司之一，其总部位于北京的中央商业区。西安杨森是强生公司的一员。从创立之初，西安杨森就致力于引进和生产许多创新产品和高质量产品。西安杨森一直致力于投资未来，计划增加在生物制品、心脏病学、风湿病学和泌尿科学领域的新系列产品。西安杨森致力于利用这些新药改善中国患者的医疗保健状况。 本着公司信条和关爱精神，西安杨森一直是活跃的企业公民，在医药、公共卫生、药物研发领域和企业社会责任方面从事了五十多项合作项目。例如，西安杨森与中国卫生部国际卫生交流与合作中心合作创立了“吴阶平医学研究奖和保罗•杨森药学研究奖”，旨在鼓励医药学领域的工作者不断创新。在过去的17年中，共计305名杰出医药学工作者在45个专业领域获得了该奖项，他们在科研领域做出了大量有价值的创新。 此外，西安杨森也被誉为培养制药行业人才的摇篮。1999年，西安杨森被财富杂志（中文版）评选为“中国最受敬仰的十大外资企业之一”。2005年，西安杨森被中国中央电视台评选为“***雇主”，并且分别在2008年、2009年和2010年获得了“中国大学生***雇主奖”。 目前西安杨森所有的招聘信息仅通过前程无忧，智联招聘和猎聘网进行发布，任何在非上述三家招聘网站看到的信息均非西安杨森正式发布。为避免对您的合法权益造成伤害，请务必通过正规渠道投递简历。 2013年，强生在西安高新区投资兴建强生全球供应链先进的生产基地，该项目建设目前已正式启动。新生产基地占地267,000平方米，将取代西安杨森在西安新城区现有的生产基地，成为强生供应链在亚洲的创新枢纽，从而更好地满足中国和其他新兴市场不断增长的需求。新的生产基地将采用世界***的制造技术和先进的质量体系，并引进集电子批号记录和数据存储于一身的全自动化配方生产操作系统以及先进的德国进口生产工艺设备。

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