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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 >临床研究经理招聘

临床研究经理

  • 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 ChinesePharmaceutical company listed in Hong Kong Stock Exchange withoncology-dominated innovative product portfolio and international growthstrategy. CSPC is looking for a full time Global Clinical Study Manager(GCMS) to manage ongoing and future clinical studies to be conducted inUS.

Working with the Clinical Project Managers (CPM) in US, theGCMSisresponsible 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 ofclinical studies
• Provide medical assessments on safety events and trial related data
• Generate and/or review all the documentsnecessary for studyinitiation, such as but not limited to, protocol, CRF, IB, etc.
• Review all the documents related to study result publication, such asbut not limited to, TFLs, CSR, manuscripts, etc.
• Contribute to NDA preparationand submission in US, EU and Japan, byworking with global regulatory team and local medical group
• Maintain routineand efficient communication with global team forongoing studies
• Ensure compliance with international GCP guidelines/regulationsandcompany SOPs
• Participate in quality assurance activities and coordinate resolutionof audit findings
• Ensure audit-ready condition of clinical trial documentationsincluding TMF
• When needed, contribute to other company related business, such as butnot 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 forclinical research
• Excellent English communication skills (both verbal and writing)
• Strong organizational skills with problem solving and team buildingskills
• 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

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

单位概况

石药集团中奇制药技术(石家庄)有限公司
近两周应聘简历处理率:33%
制药/生物工程
医药企业 其他
100~499人
黄河大道226号
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