长沙招聘

JOB TITLE: Clinical Research Manager



Location: Beijing



PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB



Responsible for trials with complex protocols, which require technical specialization, requires the ability to interface with investigators/doctors. Provides guidance & advice to more junior level CRAs & Project Teams, Summarize and share with RA people CT study experience. Set up CT strategy and overall control CT timeline both imported products and local product.

1.Ensure the implementation of project plans as assigned.

2.Be responsible for plan and protocol writing, data controlling, data reporting, and final report writing.

3.Be responsible for site selection, site qualification, site monitoring, site management, site administration and registry management for clinical studies according to GCP, ICH Guidelines, and local regulation.

4.Be responsible for CROs selection as required.

5.Coordinate complex studies at multiple sites potentially involving teams of CRA(Clinical Research Associate).

6.Prepare clinical trials, including selecting & qualifying sites, researching & writing trial plans and protocols, setting-up, equipping & training sites.

7.Prepare clinical trials, including selecting & qualifying sites, researching & writing trial plans and protocols, setting-up, equipping & training sites.

8.Conduct & monitor clinical trials, coordinating all contact with the sites, problem solving, analyzing data, as well as building & maintaining relationships with investigators & the sites.

9.Select CROs as appropriate and negotiate related contracts.

10. Lead reviews of data periodically & keep Project Team informed.

11.Lead problem solving & troubleshooting efforts on technical issues.

12.Lead preparation of final trial reports & close the trial.

13.Lead technical reviews to launch & close trials.

14.Collaborates with investigators on scientific posters & papers.



KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB



Experience & Personality:

1.5-7 yrs clinical research experience in China,

2.MSc in a scientific field (ex biology, pharmacy,) ;



Education & Knowledge:

1.Scientific background preferred

2.Deep knowledge of monitoring procedures.

3.Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements.

4.Basic knowledge of clinical trial process.

5.Ideally knowledge in: In vitro diagnosis; Chinese regulation;

6.Chinese native speaker; Fluent English.

      生物梅里埃公司创建于1963年，公司以来自身的科技创新和工业生产资源，始终致力于医疗和工业用途的体外诊断产品。生物梅里埃的诊断系统由试剂、仪器和软件组成，主要围绕感染性疾病、工业微生物、心血管病和肿瘤四个战略领域设计。生物梅里埃的使命是通过体外诊断，为全球公共卫生事业做出贡献。
      目前，生物梅里埃在全世界拥有19个工业生产工厂；20个研发基地；业务遍及世界六大洲160个国家，在44个国家和地区设有分支办事机构；全球雇员近13000人。凭借55年的经营，生物梅里埃如今在全球体外诊断行业扮演着重要的角色，在全世界诊断企业排名中位列前十，是临床微生物学和工业微生物学领域的翘楚。
      放眼未来，生物梅里埃将继续秉承传统、恪守承诺，全力为客户研发和提供***整体解决方案，力争成为推动全球公共卫生事业发展的领导者。