Clinical Study Lead 北京

月薪： 1.5-2万/月

该公司所有职位
  • 无工作经验
  • 招1人
  • 11-09 发布

职位描述

职位描述： 职责描述：Responsible for trial design, planning (timeline and budget) and accountable for clinical study projects in China territory of Qiagen organization by coordinating with activities and stakeholders internally and externally.Ensure compliance to SOPs, GCP policy, and relevant CFDA regulations in the operation of clinical study.Responsible for tracking of timeline and budget, ensuring complete trial in a timely manner within budget, and raise up potential issues timely, setup internal and external communications for correction, trouble shooting, and prevention plan.Draft and implement all study associated documentation including ethical application, CFDA files of trial, study protocols, contracts, site files, audit reports, and study reports.Review all source documentation, monitor reports, site record, and data for accuracy and ensure timely submission and safe storage of all documentation.Execute site survey/selection, guide lab preparation, instrument/reagent setup, kick-off meeting/training, logistic of consumables supply and inventory in line with regulations.Lead CRA/CRC (internal and external) to plan site monitoring, and ensure good monitoring quality in terms of documentation, enrollment progress, data records. Lead data specialist for database design, database implementation on site, integrity check planning, and statistic strategy.Coordinate communications with investigators, and participate discussions with CFDA relevant reviewers / guideline drafter if necessary任职要求：At least 4 years IVD clinical trial related experiences, Pharma trial experiences could be considered as well, better clinical project management roles.Strong and solid IVD or bio-tech knowledge, medical or clinical lab related backgrounds preferred.Proficiency of English oral communication, and technical reading and writing.Excellent knowledge in CFDA regulation, ISO international standards, and relevant clinical trial guidance.Strong ability in inter-personal skill, project management skill, problem-solving mindsetWillingness of travel (up to 20%) 职能类别： 临床研究员 生物工程/生物制药

联系方式

北京市朝阳区太阳宫

公司信息

QIAGEN is the leading provider of sample and assay technologies. Sample technologies are used to isolate DNA, RNA and proteins from any biological sample. Assay technologies are then used to make specific target biomolecules, such as the DNA of a specific virus, visible for subsequent analysis. We have developed more than 500 consumable products and automated solutions. We are the market leader in academic research markets, to leading pharmaceutical and biotechnology companies, to molecular diagnostics laboratories as well as applied testing markets such as forensics, animal or food testing, and pharmaceutical process control. QIAGEN employs more than 3,900 people in over 35 locations worldwide. QIAGEN公司在全球35个国家，有着超过3900名员工和一支国际化的管理队伍。行业领先的技术使我们在未来能够持续成长和保持领先地位。 我们致力于全球生物技术市场。我们有着全球网络，代理商服务国家超过42个。同客户的紧密联系使得我们能够不断保持处于技术前沿，不断满足市场需求，不断完善我们产品发展系统。 从1986年以来，我们已经完善和上市了许多科研产品和工业的产品，应用于核酸纯化技术等方面，如：生命科学研究，基因组研究，基因药物发现，核酸分子诊断，基因疫苗和基因治疗市场等。核酸纯化市场的快速发展促使我们不断完善核酸纯化技术。

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