工作职责：1. As a project leader to lead the whole study activities, including but not limited to site selection, Ethic's committee review, study agreement signing, investigator meeting, enrollment, trial master file management, site monitoring, source data varification and site close-out. 作为项目负责人，负责临床研究的整体实施与管理，包括但不限于研究中心选择，伦理审批，研究协议签署，研究者会的召开，入组，研究文档管理，研究中心监查，原始数据核查，研究中心关闭等。 2. As a project leader to manage and track the study timeline, study budget and products of company sponsored studies. 作为项目负责人，管理并跟踪公司发起研究的时间进度，研究预算和研究产品。 3. Ensure the clinical studies are in compliance with local regulations, ICH GCP and Roche SOPs. 确保所有研究符合当地法律法规的要求，ICH GCP以及罗氏SOP。 4. Manage the review and approval processes of investigator initiated studies and track the study progress. 负责对研究者发起的研究进行审核和批准流程的执行，并跟踪研究进展。 5. Work with global MSA and clinical operation team to have a cooperation on global multicenter studies. 与罗氏总部MSA及临床研究团队合作进行国际多中心研究。 6. Establish and maintain the good relationship with KOLs, investigators and sites. 与意见领袖以及临床研究的研究者保持良好的沟通。 7. Assist line manager in other clinical study related tasks or other routine tasks. 协助直线经理进行其他的研究相关工作以及其他日常工作。
任职资格：ducation& Qualifications教育背景与专业资格: - Master / Bachelor Degree in Clinical Medicine or Clinical laboratory education background, PhD Degree is preferred. Experience工作经验: -3-5 years of diverse healthcare experience in medical or clinical research in pharmaceutical, medical device or IVD companies.
