Clinical Trial Specialist 北京

月薪： 20-40万/年

该公司所有职位
  • 3-4年经验
  • 招1人
  • 01-23 发布

职位描述

Responsibility:1. Act as key contact person to support the local study teams on the preparation of HGRA submission dossier, submit the HGRA approval application and ensure the HGRA approval, sample exportation approval and CIQ approval, in line with HA related regulations and requirements.2. Proactively negotiate with HGRAC and hospitals to ensure each permit application successful and each batch permit of trial samples to be exported successfully, per the trial plan.3. Maintain HGRA application, approval and samples exportation related data tracking, as well as the relevant files archiving.4. Proactively work with local study teams to collect the data, address the issues and concerns to respond the internal/external environment change, and to proactively provide the inputs on the sample exportation application process optimization and issues resolution, supported by Functional Manager, GCO Q&C and stakeholders.5. Where applicable, provide the training and or the updates on the sample exportation related regulations/process to the dept. and cross functions.6. Act as Liaise with Finance teams, Legal, HCC, Procurement, C&G, GCO Q&C, and other stakeholders to obtain guidance and escalate issues as appropriate.7. May act as SME member, proactively contribute to the process improvement including responsible functional areas, but not limited, in process initiatives and contribute to optimization of daily processes.8. May act as ARIBA Super user to submit the request of PO setup, and follow up the PO related issues resolution with the stakeholders Finance, HCC etc.9. May act as Local Archiving Coordinator to coordinate the management of Department/Trial related files archiving, input on the local archiving SOP/WI updates, supported by Functional Manager, GCO Q&C, and other stakeholders.10. May act as Trial Supply Coordinator to coordinate the management of trial supplies, proactively provide the inputs on the supply process optimization, issues address and resolution, with the support of Functional Manager, Procurement, Legal and other stakeholders.11. May act as Contracting Coordinator to collect the data, address the issues and concerns to respond the internal/external environment change, proactively provide the inputs on the contracting cycle time shortening process optimization and issues resolution, supported by Functional Manager and stakeholders.12. Comply with requests from QA and auditors.13. Partners with the LTM and Site Manager to ensure overall site management and adherence to internal SOPs, policies and local regulatory requirements.14. In liaison with the LTM, ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes.15. Where applicable, works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority (if applicable) approval process.16. Supports the LTM or, where applicable the SM, in providing the current and complete documents requested by the IEC/IRB and HA.17. Supports the SM/LTM in collecting and maintaining all documents throughout the trial and post-trial in both vTMF (i.e., IF/LAF sections) and paper files.18. Distributes, collect, review, and track regulatory documents, agreements and training documentation.19. May be assigned as a coach and mentor to a less experienced CTA.20. Complies with relevant training requirements.Qualification:–A minimum of a BA/BS degree is preferred.–Skills set corresponding with preferentially 4+ years’ relevant clinical trial experience or equivalent.–Proficient in English language. Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint)–Strong interpersonal and negotiating skills.–Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.–Perform activities in a timely and accurate manner.–Proficient in the English language. 职能类别： 临床研究员 医药技术研发人员

联系方式

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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