临床操作质量专员
诺思格（北京）医药科技开发有限公司
- 公司规模：150-500人
- 公司性质：合资(非欧美)
- 公司行业：制药/生物工程 医疗/护理/卫生
职位信息
- 发布日期：2012-11-09
- 工作地点：北京-海淀区
- 招聘人数：若干
- 学历要求：本科
- 语言要求：英语良好
- 职位类别：药品生产/质量管理 临床研究员
职位描述
CORE JOB TASK
w Implement and deliver the agreed upon R&G QC plan which includes risk management, to assist Clinical Operations to deliver a better compliance with relevant ICH, GCP, country regulations and guidelines.
w Participate in R&G and department system/standards improvement activities.
w Contribute to the development of and responsible for implementation and delivery of specific initiatives as defined and agreed upon.
w Provide advice and support to local Clinical Operations, including Project Managers and other key local stakeholders with regard to quality control, risk assessment and management, and corrective actions.
w Provide technical support to CRAs to ensure that they have the required knowledge to fulfill their duties.
w Conduct co-monitoring per QC plan, mentor and coach CRA when applicable.
MINIMUM REQUIREMENTS
w A Bachelor Degree in a medical, health, or science related are, or a nursing degree.
w Minimum of 3 years related experience in clinical trial management or related areas including at least 1 years CRA experience.
w Good understanding of Phase I - IV quality assurance principles, clinical monitoring procedures, all relevant GCP guidelines and of local and international regulations.
w Knowledge of medical terminology and high proficiency in Microsoft Word / Excel / Powerpoint / Outlook
w Excellent, interpersonal, communication and organizational skills.
w Good team player, self-motivated and attention to details.
w Strong customer focused sensitivity towards internal and external customers.
w Able to travel when required.
w Implement and deliver the agreed upon R&G QC plan which includes risk management, to assist Clinical Operations to deliver a better compliance with relevant ICH, GCP, country regulations and guidelines.
w Participate in R&G and department system/standards improvement activities.
w Contribute to the development of and responsible for implementation and delivery of specific initiatives as defined and agreed upon.
w Provide advice and support to local Clinical Operations, including Project Managers and other key local stakeholders with regard to quality control, risk assessment and management, and corrective actions.
w Provide technical support to CRAs to ensure that they have the required knowledge to fulfill their duties.
w Conduct co-monitoring per QC plan, mentor and coach CRA when applicable.
MINIMUM REQUIREMENTS
w A Bachelor Degree in a medical, health, or science related are, or a nursing degree.
w Minimum of 3 years related experience in clinical trial management or related areas including at least 1 years CRA experience.
w Good understanding of Phase I - IV quality assurance principles, clinical monitoring procedures, all relevant GCP guidelines and of local and international regulations.
w Knowledge of medical terminology and high proficiency in Microsoft Word / Excel / Powerpoint / Outlook
w Excellent, interpersonal, communication and organizational skills.
w Good team player, self-motivated and attention to details.
w Strong customer focused sensitivity towards internal and external customers.
w Able to travel when required.
公司介绍
诺思格（北京）医药科技开发有限公司是中国最具前景的CRO公司，提供国际标准的临床研究外包服务。业务涵盖新药评估与咨询、注册事务、临床试验实施、数据管理和统计分析、医学事务及培训等全方位服务。管理团队和执行团队由业内最资深的人员组成，整个团队凝聚、稳定、和谐，为客户提供专业、高效的服务。
我们的使命：致力于人类的健康
我们的愿景：成为全球最优秀的医药研发服务公司
我们的文化：敬业、忠诚、和谐、诚信、专业、高效
我们的理念：
对客户----专业、诚信、保障
对员工----凝聚、和谐、成长
对同业----交流、合作、发展
对社会----热爱、责任、奉献
“创新是我们的灵魂，执行是我们的生命”
详情请登录公司主页： www.rg-pharma.com
接收简历邮箱：zhaopin@rg-pharma.com
我们的使命：致力于人类的健康
我们的愿景：成为全球最优秀的医药研发服务公司
我们的文化：敬业、忠诚、和谐、诚信、专业、高效
我们的理念：
对客户----专业、诚信、保障
对员工----凝聚、和谐、成长
对同业----交流、合作、发展
对社会----热爱、责任、奉献
“创新是我们的灵魂，执行是我们的生命”
详情请登录公司主页： www.rg-pharma.com
接收简历邮箱：zhaopin@rg-pharma.com
联系方式
- Email：zhaopin@rg-pharma.com
- 公司地址：北京海淀区车公庄西路 19 号华 通大厦 B 座北塔11 层
- 邮政编码：100048