长沙招聘

岗位是外派到合资肿瘤创新药企，负责国际多中心肿瘤项目

工作职责：

1.负责整个研究，定期向临床部经理汇报项目进展情况和存在的问题，寻求高效的解决措施；

2.负责控制整个项目的预算；

3.与申办方及时沟通和汇报试验中存在的问题，并积极协调和解决问题；

4.确保项目按照GCP及相关法律法规要求执行，控制试验的质量和进度；

5.及时应对解决申办方协同访视发现的问题（及时审阅回复相关邮件、电话等，对CRA进行指导和督促）；

6.管理团队，通过不同途径与监查员进行沟通，传达关于项目进展的策略；

7.定期/不定期的根据项目进展需要，组织和召开项目内部会议；

8.负责协调方案、CRF、ICF等其他试验所需文件和工具的制定和审核；

9.参加部分中心的启动会议，通过协同访视控制中心的试验质量；

10.督促CRA严格按照项目管理计划进行和实施监查及相关工作的汇报；

11.指导和协调CRA进行与各研究中心合同的谈判与签署，及时向申办方反馈合同签署过程中需要解决的问题；

12.负责审核CRA所负责中心的监查报告；审核项目相关会议记录；

13.向申办方汇报项目进展，向项目组传达进展情况；

14.对项目进行风险管理，提前制定应对方案与计划；

任职要求：

1、学历本科、医药学相关专业、英文读写良好；

2、工作经验要求有3年及以上CRA工作经验（药厂、CRO），1年以上项目管理经验，有肿瘤项目经验优先考虑；

3、善于与他人沟通，有良好的服务意识以及较强的应变能力，能够统筹规划安排工作。

4、熟练使用各种办公软件及设备。

5、抗压能力好，有责任心，谨慎细致，条理性强；

  Beijing Health Tech Medical Group (HT-Med) was founded since 2004. We are a comprehensive medical Operation and development organization .Assemble excellent talents of medicine, pharmacy, data management and statistical fields, offering professional services to support biotech and pharmaceutical companies at every stage of product lifecycle .
 
 We provide Medical translation, Data Management, Statistical Analysis, Medical Writing, Regulatory Affairs, Project Evaluation and Management, Independent Audit, Training, CRA/CRC/DM dispatch. Since we established, we were developing new drugs with Chinese Academy of Medical Sciences, Peking University Health Science Center, The General Hospital of the PLA, Military Medical Sciences, etc. Has cooperated with over 90% clinical trial sites (hospital) approved by SFDA.

  We developed independently EDC+CTMS by ourselves, obtained 3 patents and 2 brands. Basing on excellent IT capability, we develop Products Data Center for our clients, and created role exchange pattern between CRA and CRC, improved speed&quality of Clinical Study by the model of EDC+CRC, especially in PMS. We have been became the vendor of lots of global company (AZ, GSK, BI, Abbott, Roch, Mundipharma, QPS etc.) and some official Institution (Chinese Academy of Medical Sciences, Peking university, The general hospital of Chinese PLA, Sanming hospital, Zhejiang oncology hospital, Academy of Military Medical Sciences of the Chinese PLA etc.).

 We are familiar with China SFDA policy and CDE mentality, possessing mass of expert resource and marketing support. we could cover 90% Chinese certificated clinical research hospital by lots of home-based employee in 18 cities.

  公司邮箱：yanmei.wang@ht-med.com
  公司网址：http://www.ht-med.com