Sr. Clinical Research Specialist, Beijing
赛诺秀（中国）
- 公司规模：50-150人
- 公司性质：外资（欧美）
- 公司行业：贸易/进出口
职位信息
- 发布日期：2017-07-18
- 工作地点：北京-朝阳区
- 招聘人数：1人
- 学历要求：本科
- 语言要求：英语 精通
- 职位月薪：1.5-2万/月
- 职位类别：临床研究员
职位描述
职位描述：
Overview:
Coordinate with Sr. Clinical research manager APAC to develop and deliver clinical evidence to internal & external stakeholders.
Responsibilities:
? Assist in managing study activities at assigned investigational sites in China
? Oversee the preparation of the documentation for submission to EC
? Perform initiation, regular monitoring and close out visit to investigator site in compliance with study monitoring plan, company SOPs, local regulations, and ICH GCP. Prepare and submit accurate and timely site visit reports for all performed visits
? Responsible for maintenance of central files and electronic database including filing, quality checks archiving of clinical study information
? Verify the accuracy, completeness and legibility of the data collected in the studies
? Ensure all case report forms can be collected and queries can be resolved in timely manner
? Ensure all adverse events occurred in the study be reported in compliance with study as well as regulation requirement
? Verify the trial supply is stored, transferred, and tracked appropriately. And unused investigational product and other study supplies is returned or destroyed properly after the completion of study
? Assist in the preparation for the internal or external audit/ inspection. Resolve issues cited in audit reports
? Communicate with internal and external business partner in terms of project progress and outstanding issues
? Perform effective and efficient vendor management to ensure the services vendor provided are satisfied and qualified in compliance with Cynosure policy, SOP and other related requirements
? Other duties as required
Qualifications:
? Minimum of 3 years experience in a medical device, pharmaceutical company or CRO for clinical research execution, including at least 1 year project management experience
? Demonstrated communication / interpersonal skill (oral and written)
? Self-motivated individual who can manage multiple tasks and priorities in an efficient manner
? Proactive and organized with exceptional follow-up
? Anticipate/ identify problems and takes appropriate action to correct
? Conscientious and precise delivery of work even when under pressure
? Knowledge of ICH GCP, and CFDA regulations, research process and scientific knowledge as relates to clinical trial conduct
? Adequate English verbal and written skills
? Willingness to travel
? Bachelor’s degree & above, Biomedical Engineering/ Clinical Medicine/ Life Science preferred
举报
分享
Overview:
Coordinate with Sr. Clinical research manager APAC to develop and deliver clinical evidence to internal & external stakeholders.
Responsibilities:
? Assist in managing study activities at assigned investigational sites in China
? Oversee the preparation of the documentation for submission to EC
? Perform initiation, regular monitoring and close out visit to investigator site in compliance with study monitoring plan, company SOPs, local regulations, and ICH GCP. Prepare and submit accurate and timely site visit reports for all performed visits
? Responsible for maintenance of central files and electronic database including filing, quality checks archiving of clinical study information
? Verify the accuracy, completeness and legibility of the data collected in the studies
? Ensure all case report forms can be collected and queries can be resolved in timely manner
? Ensure all adverse events occurred in the study be reported in compliance with study as well as regulation requirement
? Verify the trial supply is stored, transferred, and tracked appropriately. And unused investigational product and other study supplies is returned or destroyed properly after the completion of study
? Assist in the preparation for the internal or external audit/ inspection. Resolve issues cited in audit reports
? Communicate with internal and external business partner in terms of project progress and outstanding issues
? Perform effective and efficient vendor management to ensure the services vendor provided are satisfied and qualified in compliance with Cynosure policy, SOP and other related requirements
? Other duties as required
Qualifications:
? Minimum of 3 years experience in a medical device, pharmaceutical company or CRO for clinical research execution, including at least 1 year project management experience
? Demonstrated communication / interpersonal skill (oral and written)
? Self-motivated individual who can manage multiple tasks and priorities in an efficient manner
? Proactive and organized with exceptional follow-up
? Anticipate/ identify problems and takes appropriate action to correct
? Conscientious and precise delivery of work even when under pressure
? Knowledge of ICH GCP, and CFDA regulations, research process and scientific knowledge as relates to clinical trial conduct
? Adequate English verbal and written skills
? Willingness to travel
? Bachelor’s degree & above, Biomedical Engineering/ Clinical Medicine/ Life Science preferred
职能类别： 临床研究员
公司介绍
苏州赛诺秀医疗器械有限公司成立于1996年，由苏州医疗器械总厂和美国赛诺秀公司(Cynosure, Inc. USA)共同合资成立。2006年11月美国赛诺秀公司收购了苏州医疗器械总厂持有的公司股份, 由此苏州赛诺秀公司成为美国赛诺秀公司在华唯一的独资子公司。
苏州赛诺秀医疗器械有限公司主要致力于将美国赛诺秀公司的高科技医疗激光器引进中国，经过二十多年的努力经营，公司取得了良好的经济效益和社会效益、赢得了国内广大客户的信赖和欢迎，并在业界享有极高的声誉。
2017年2月美国赛诺秀公司被全球领先的专注研发、生产和销售女性健康设备的美国Hologic公司收购、成为其独资子公司， 强强联合将给美国赛诺秀公司带来更好的机遇和发展。
我们的产品
美国赛诺秀公司的系列产品展现了其他产品无可比拟的多变性和灵活性，在医疗美容产品的研究和制造方面都处于行业的领先地位。
可以广泛地运用于各种医学美容治疗，例如各种良性皮肤血管性损伤、各种良性色素性损伤、脱毛、嫩肤、去疤、痤疮、塑身等。
苏州赛诺秀医疗器械有限公司主要致力于将美国赛诺秀公司的高科技医疗激光器引进中国，经过二十多年的努力经营，公司取得了良好的经济效益和社会效益、赢得了国内广大客户的信赖和欢迎，并在业界享有极高的声誉。
2017年2月美国赛诺秀公司被全球领先的专注研发、生产和销售女性健康设备的美国Hologic公司收购、成为其独资子公司， 强强联合将给美国赛诺秀公司带来更好的机遇和发展。
我们的产品
美国赛诺秀公司的系列产品展现了其他产品无可比拟的多变性和灵活性，在医疗美容产品的研究和制造方面都处于行业的领先地位。
可以广泛地运用于各种医学美容治疗，例如各种良性皮肤血管性损伤、各种良性色素性损伤、脱毛、嫩肤、去疤、痤疮、塑身等。