职位描述

岗位职责: 1、Prepare site GCP/EC documents, reviewing for completeness and accuracy and submit toassigned sites 2、Review, prepare and negotiate site contracts and budgets with sites, if applicable. 3、Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. 4、Ensure contracts are fully executed unless special situation, EC documents and approvals are granted, Reviews essential document packages for site activation and IP Release authorized, may also be involved in essential document collection from site. 5、Review and provide feedback to management on site performance metrics. 6、Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines. 7、Inform team members of completion of regulatory and contractual documents for individual sites. 7、May translate or review or verify completed translations of critical documents. 8、May support in feasibility and/or site identification activities. 9、May review or work with team members in preparation of regulatory submissions per work instructions, including site OHGRA filing docs, PFDA filing, etc.… 任职要求: 1、Bachelor’s Degree in life sciences or a related field and at least 1 year’ s clinical research or other relevant experience. 2、Proficiency in both written and spoken English. 3、Good interpersonal communication and organizational skills. 4、Good negotiating and communication skills with ability to challenge, if applicable. 5、Effective communication, organizational, and interpersonal skills. 6、Ability to work independently and to effectively prioritize tasks. Ability to manage projects with timeline pressure. 7、Knowledge and ability to apply GCP/ICH. 8、Knowledge of applicable SOPs and company’s Corporate Standards. 9、Ability to establish and maintain effective working relationships with coworkers, managers and clients.

其他要求

招聘人数: 1
职能类别:

公司介绍

昆翎(ClinChoice)是一家致力于为生物医药和医疗器械客户提供高品质一站式服务的临床阶段CRO,服务包括临床运营、项目管理、生物统计、数据管理、注册事务、医学事务和药物警戒。昆翎已经在中国、美国、欧洲、印度、日本和菲律宾建立了主要的临床交付中心,目前在全球拥有1800多名员工,其临床运营团队覆盖了亚、欧、北美等七个国家和地区。

高盛直投部董事总经理、昆翎董事会成员许小鸥先生认为,“随着创新疗法在全球的增长,CRO公司提供高效、可靠的研发服务能力变得尤其重要。昆翎独特的价值主张结合了其对于本地市场的了解、国际药物研发的经验以及高效的团队执行能力。我们坚信公司强劲的管理层团队以及其高效的执行能力,将为昆翎的发展开启新的篇章。

企业信息

  • 名称:昆翎(北京)医药科技发展有限公司
  • 行业:制药.生物
  • 性质: 其他
  • 规模: 5000-9999人

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