Local Trial Manager(oncology)-BJ 北京

月薪： 1-2万/月

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： Responsibilities1.Responsible for customizing the Master Clinical Trial Agreement (mCTA) including site / vendor and study specific information;2.Responsible for analyzing contract requests/needs and translating into appropriate contracts/budgets for company sponsored clinical trial agreements;3.Lead negotiation of third party contracts and budgets, ensuring the budget meets HCC/HCBI requirements (including budget verification with fair-market value) and contract contains appropriate wording for the third party4.Acts as primary local/country contact for clinical trial agreements and site specific (budget) templates with clinical trial sites. In case of legal matters, act as liaison between the local study site , Local Trial Manager and the (local) legal department;5.Calculate study budget based on results of negotiations with third parties;6.Keep cross-trial and cross-site oversight to create consistency and ensure accumulated learning and updated records from each negotiation round;7.Create local budget overviews with LTM support;8.Evaluate potential needs for contract amendments and manage amendment lifecycle; ensuring that contract amendments are appropriately executed;9.Work with the global C&G, HCC&P,legal affairs, finance teams and GCO Q&C as necessary to review and analyze contractual terms and conditions in order to reach acceptable language. Act as liaison in risks assessment of budget and legal provisions in conjunction with members of the C&G team and support functions and communicate such to stakeholders. Liaise with C&G management, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate.10.Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trials and activation of clinical trial sites.11.Comply with requests from QA and auditors.12.Responsible for managing the mCTA data oversight: provide qualitative and quantitative input into any revisions of the mCTA and maintain metrics on %adherence to mCTA standards, time to contract sign off to inform strategic discussions with the Research networks13.Establish and maintain excellent working relationships and networking with external stakeholders, in particular hospital administration and contracting and internal stakeholders, including but not limited by Legal Affairs, Health Care Compliance and global C&G14.Actively contributes to budgeting, contracting and payment to third party process improvement;15.May represent functional area in internal and external contracting initiativesRequirementsUniversity degree or other relevant tertiary education, with relevant working experience and affinity with the legal domainMinimum of (2 to 6) years of pharmaceutical and/or clinical trial experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.Solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Must have a working knowledge of the clinical development process with 2 years of negotiation and contract experienceFamiliarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, Sarbanes-Oxley,etc.)Ability to work effectively in cross function teams and able to influence individuals at all levels within multiple organisations;Ability to negotiate over conflicting issues and develop win-win outcomesPrevious experience working in virtual teams preferredMust demonstrate innovative spirit, have strong interpersonal skills, and ability to accomplish substantial tasks with minimal supervisionComputer literacy – advanced computer skills and detailed knowledge of a variety of software packages (Microsoft applications like Excel, PowerPoint, and Word …). Able to use a range of computer based systems (e.g. CTMS, internet applications, SharePoint) to track and monitor trial and investigational site-related activities.Excellent communication, negotiation, networking and interpersonal skills. Proficient in speaking and writing the country language and English. Proven track record in contract negotiation and problem resolution. 职能类别： 临床研究员

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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