丁香人才 > 职位招聘 >医药研发/制药生产招聘 >北京医药研发/制药生产招聘 >Clinical Study Manager招聘

Clinical Study Manager

  • 学历要求: 不限
  • 英语要求: 熟练
  • 年龄要求: 不限
  • 专业要求: 临床医学,基础医...
  • 工作年限: 不限
  • 月薪范围: 面议
  • 职位性质: 全职
  • 工作地点: 北京市
  • 职称要求: 不限
  • 招聘人数: 若干

职位描述

CSPC Pharmaceutical Group Ltd (“CSPC”) is a premier Chinese Pharmaceutical company listed in Hong Kong Stock Exchange with oncology-dominated innovative product portfolio and international growth strategy. CSPC is looking for a full time Global Clinical Study Manager (GCMS) to manage ongoing and future clinical studies to be conducted in US.

Working with the Clinical Project Managers (CPM) in US, theGCMSis responsible for the execution of clinical trialsto be conducted in US, EU and Japanwith focus on the following responsibilities:

Responsibilities:
• Review clinical data on a routine basis to ensure the quality of clinical studies
• Provide medical assessments on safety events and trial related data
• Generate and/or review all the documentsnecessary for study initiation, such as but not limited to, protocol, CRF, IB, etc.
• Review all the documents related to study result publication, such as but not limited to, TFLs, CSR, manuscripts, etc.
• Contribute to NDA preparationand submission in US, EU and Japan, by working with global regulatory team and local medical group
• Maintain routineand efficient communication with global team for ongoing studies
• Ensure compliance with international GCP guidelines/regulationsand company SOPs
• Participate in quality assurance activities and coordinate resolution of audit findings
• Ensure audit-ready condition of clinical trial documentations including TMF
• When needed, contribute to other company related business, such as but not limited to, in-licensing candidate evaluation, KOL management, etc.

Requirements:
• Medical degreeis required
• Minimum of 8 years ofclinical research experience
• Hands-on experience with NDA preparation in US, EU and Japan
• Knowledge of GCP, ICH guidelines and regulatory requirements for clinical research
• Excellent English communication skills (both verbal and writing)
• Strong organizational skills with problem solving and team building skills
• Ability to handle a high volume of tasks within a given timeline
• Ability to build relationships within and between the organizations

Location: Beijing, China
Report to: Head of Global Clinical Development and Regulatory Affairs
Working time: 40 hours per week.
Pay and Benefits: Attractive salary with comprehensive benefit package

If you are interested, please send your CV to chenyao@mail.ecspc.com
该单位 HR 近两周的应聘简历处理率: 67%

联系人: 张蓓
电    话:0311-67808712
地    址:黄河大道226号

石药集团有限公司始建于1938年5月,现有资产总额180亿元,员工两万余人,是中国最大的“化学原料药生产基地”和“综合制剂生产基地”之一,产品主要包括抗生素、维生素、心脑血管、解热镇痛、消化系统用药等六大系列近千个品种。目前,公司产品销售网络遍及全国和世界五十多个国家和地区。石药集团是国家科技部等三部委认定为“国家创新型企业”,拥有“石药”“欧意”“果维康”“恩必普”四个“中国驰名商标”,“石药”品牌自2005年以来连续十年入选“中国500最具价值品牌”,连续四年入选 ...详情

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