【职缺名称】专案经理 【徵才单位】台北医学大学 联合临床试验中心 【工作地址】双和医院 临床试验中心 【工作内容】 Point of contact with Sponsors, Taipei Medical University Joint clinical research center (TMU JCRC), Hospital administration/ departments, and Investigators to start or follow-up communications and activities related to clinical trials. Activities include investigator approach, site qualification visit, budget development, support of submission dossier development, internal evaluation in hospitals and JCRC, trial operation status, and study financial/payment status. - Coordinate and support sponsors for the identification, feasibility assessment and selection of investigators to undertake studies. - Support sponsors to prepare submissions and assessment of investigators and site. -Support sponsors to prepare, organize, conduct and follow-up site selection, and site initiation. -Motivate investigators and site staff to achieve a good understanding of the protocol and investigational product to ensure obligations in regards to study timelines and recruitment commitments are fulfilled -Adherence to ICH-GCP and any other regulatory guidelines and requirements. -Compliance with mandatory TMU JCRC or site SOPs. -Complete all reports accurately and within the predetermined timelines to CRC director, JCRC/OHR or per hospital requirements. -Maintenance of study information required for Clinical Trial Management System. -Be notified of contract/study milestones. -Notify and follow-up actions to take for each study milestones (e.g., payment milestones, enrollment status, study close out). -Act as a company representative to promote company business. -Participate in the professional meetings, symposia, and conventions to maintain professional competencies. -Other assignments from relevant supervisors. 【徵才条件】 At least 2 year experience in clinical trials as CRA, PM ore study coordinator within a CRO pharmaceutical/biotech company or site. - Understanding of medical terminology and physiology. - Working knowledge of ICH/GCP, ethical and regulatory requirements. - Good interpersonal skills, presentation skills and the ability to work well and autonomously, in small teams and with a wide range of varying stakeholders. - Familiarity with computer systems particularly MS Word, PowerPoint, Excel, electronic data capture and project management systems. - Ability to see the big picture yet still focus on detail and quality. Act in a lead role. - Demonstrate effective time management and organizational skills. - Ability to work within a flexible team environment on multiple projects simultaneously. - Self-motivated, tenacious and displays initiative. - English proficiency is a plus (Medium to Business level) 工作经历：相关经验 2年以上 学历要求：大学、硕士 科系要求：公共卫生相关、护理助产相关、其他医药卫生相关 【薪资待遇】50,000元起，依相关经验可再谈 【联络方式】请利用104人力网回传履历 或 mail至[email protected] 李小姐 收 【其他备注】意者请备简历、自传e-mail至邮件 主旨请注明「应徵专案经理_姓名」，合者通知面谈。 --

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