赛默飞世尔科技 · Clinical Research Group临床研究部门

CRP医学经理-总监 (心血管/血液/肿瘤/免疫)

薪资面议  /  全国

今天 14:02 更新

我要推荐 内部推荐

若你发现本职位存在违规现象,欢迎举报。

提交成功

3s后自动关闭

举报职位

职位描述

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Discover Impactful Work:

The Clinical Research Physician will provide medical support and medical advice for clinical trials and safety evaluation within the Pharmacovigilance department.

A day in the Life: Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific information, contribute to site selection, involved in review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trials

Real time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early. Pro-active customer concern and correction of issues in consultation with the Global Medical Indication Lead

During initial review of protocol, consults with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent protocol amendments. Acquires other functions’ dedication to close gaps and address issues timely and effectively. Serves as chief liaison between sponsor and all PPD, part of Thermo Fisher Scientific internal departments performing the required tasks during all study phases

Medical point of contact for all internal and external stakeholders: Interact with the investigators as needed, answer questions of IRBs and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable; medical training of site staff at Investigator meetings; CRA training in new indications

Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties 

任职条件

Education

MD, MB/BS or equivalent degree and strong medical knowledge, shown clinical experience running Cardiovascular/Oncology/ Hematology/autoimmune patients in hospital practice.

Knowledge, Skills, Abilities

Significant experience within pharmaceutical industry, clinical trials and pharmaceutical medicine is critically important

Is fluent in spoken and written English

Shown understanding and experience with NDA submission process.

Shown understanding of regulatory guidelines for adverse event reporting

Strong communication & presentation skills and is a strong teammate

职位属性

招聘类型:社招
工作性质:全职

职位要求

  • 学历要求:本科
  • 外语要求:英文Workable

公司福利

  • 13薪+商业保险
  • 年终奖金
  • 带薪年假
  • 住房、节日津贴
  • 丰富的员工活动
  • 荣获“健康工作场所国际认证”
  • 免费班车
  • 茶歇零食
  • 自有食堂