Senior Clinical Data Acquisition Expert招聘_西安杨森制药有限公司最新招聘信息-猎才医药网

职位描述

Summary: The position is primarily accountable for providing expertise in technical clinical data management activities, including, but not limited to, CRF technical development, data model specifications and mapping, data stream integrations, programs, reports and visualizations for data review, eCRF submission packages, and use of novel technologies and systems in the data management space. The incumbent will partner with Global Data Managers and Standards experts, where applicable, to evaluate and propose optimal technical solutions to meet protocol requirements and determine implementation plans (e.g., leverage CRO expertise, program internally, deploy new system, create new standard) as well as provide hands-on programming as appropriate in support of a trial. The incumbent will ensure high level of consistency and quality within and across trials. This position acts as a deployment expert in the technical aspects of data management to ensure latest standards are being utilized, current technologies are deployed and system integrations are optimized. At the trial level, this position will drive use of standards for CRF builds and ensure best practices are used for edit checks, reports, and integrations. Additionally, this position will determine, in conjunction with the team, the data models required (SDTM, non-SDTM), will review data models for compliance with standards and will assist with the creation of new CRF, edit check, mapping and submission standards if needed. This position is accountable for the delivery of technical data management components of the trials – data collection with integrations, reports and checks for data quality review and appropriately formatted datasets (SDTM or other) including the full e-submission ready data package. This position works together with the Global Data Manager to ensure the solutions are optimal to deliver the trial data content. This position requires minimal oversight. Responsibility: 1. Ensure eCRF is built according to the latest standards and best practices, including edit checks and applicable integrations (IWRS, CTMS, etc); translate protocol requirements into optimal data capture approaches; oversee eCRF build and updates by CRO or vendor to confirm quality. 2. Provide specifications for data models to be used for quality review and for final data model (SDTM or other); design mapping algorithms for non-standard conversions. 3. Ensure quality review of datasets (e.g., Pinnacle 21 compliance checking); ensure datasets are available for stakeholder use (medical review, central monitoring, adaptive design, etc) and compliant for Database lock. 4. Program, or oversee programming of, quality review checks and reports for use by Global Data Managers and other team members. 5. Ensure non-eCRF technologies for data capture (e.g., ePRO, safety reporting, coding, IWRS) are deployed as per requirements, including integrations with other systems, platforms or reporting environments with timelines for consumable data outlined. 6. Oversee development of data transfer agreements with ancillary data vendors ensuring use of standards, fit-for-purpose data models and transfer intervals. 7. Develop and maintain working knowledge and expertise in programming languages utilized in data management (SAS, SQL, etc) and apply continuous learning as data management platforms evolve. 8. Responsible for creation of submission-ready SDTM packages for FDA/PMDA or other regulatory authority submissions and keeping abreast in changing regulatory requirements. 9. Responsible for acquiring and maintaining working knowledge in the various and future evolving data collection tools applied in the clinical trial space such as Medidata Rave, Clinical Data Tools such as LSAF, Pinnacle 21, and in CDISC standards such as SDTM, CDASH, Controlled terminology and define.xml. 10. Support the development of standards and drive their implementation within the organization Qualification: Bachelor’s degree or equivalent work experience is required;Minimum of 3 Years of experience in data management (data review, database management, standards development, statistical or data management programming, CRF build, etc)Knowledge of protocol and current clinical drug development processeKnowledgable of international guidelines regarding clinical trials end to endWorking knowledge of an eDC system, e.g. Medidata platform of tools, Clinbase eCOS, etc.SAS programming skills or other analytical programming languageWorking knowledge of reporting tools, e.g. SpotfireWorking knowledge of SDTM including Define.xml , CDASH, metadata and ADAMAbility to work with cross-functional team interpreting data requirements.Proven knowledge of good data management practicesProven project management skillsVendor management oversight experience 职能类别：临床数据分析员关键字： Data Management

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。

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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