上海相关职位: 仓库管理员 蛋白药物表征分析高级研究员 蛋白质药物表征高级科学家/经理 理化分析高级研究员/主管 文件管理员 细胞培养高级研究员 抗体药物生物学活性分析经理 实验室管理 QA计量和验证专员 BA研究员
周边城市招聘: 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南
企业入驻日期: 2017-11-09
Job responsibility:- Manages the protocol execution at hub level.- Coordinates and maintains effective communication with sites upon request and could be a contact for investigators when necessary.- Provides feedback and status updates to internal stakeholders on an ongoing basis.- Demonstrates an understanding of the overall project goals, the indication studied and the purpose of the assigned study in meeting the objectives of the project.- Work closely with other study team members in the coordination of study activities to meet the appropriate timelines at the site/protocol level.- Communicates information and issues to team and stakeholders to ensure that site management activities, protocol executions and study documentation are in compliance with study timelines. ICH-GCP guidelines, SOPs and local regulatory guidelines or regulations.- Provides ongoing training and mentoring to team members through a mentoring process using informal and/or formal presentations.- Understands how the issues of a single study can impact the overall project and contributes to establishment of best practice through coaching and feedback.Job requirements:- Knowledge equivalent to that attained with a Bachelor’s degree in Clinical Medicine, Pharmacy, Nursing and clinically related or relevant experience.- Thorough understanding of ICH-GCP guidelines, China GCP guidelines and China Regulatory guidelines Knowledge of general clinical research including investigator site issues, important milestones and strategies to ensure timelines are met.- Knowledge of the pharmaceutical industry and of the pre-clinical, clinical, regulatory and commercial components.- Experience as an Lead CRA(Monitor)/ Senior CRA (Monitor) or equivalent experience within the pharmaceutical industry.- Experience with aspects of project management.- Experience in the conduct and management of Investigator sites from start-up to database lock within expectations set by management. 职能类别: 临床研究员
上海市南京西路1717号,会德丰国际广场17楼
中美上海施贵宝制药有限公司(SASS)是百时美施贵宝公司(BMS)在中国的投资企业,于1982年成立,是中国第一批中美合资制药企业,其以先进技术、现代管理、优质产品和良好业绩闻名全国。被《财富》评为世界五百强企业之一的百时美施贵宝公司是从事医药及相关保健产品生产的全球性企业,它的使命是‘延长人类寿命,提高生活质量’。本公司崇尚团队合作及员工的热忱参与,承诺对每位员工提供一个安全、宽和、激励的工作环境和具有竞争力的薪酬福利。我们欢迎有识之士与我们一起共创未来。 关于公司的更多信息请浏览网站http://www.bms.com.cn。
上海相关职位: 仓库管理员 蛋白药物表征分析高级研究员 蛋白质药物表征高级科学家/经理 理化分析高级研究员/主管 文件管理员 细胞培养高级研究员 抗体药物生物学活性分析经理 实验室管理 QA计量和验证专员 BA研究员
周边城市招聘: 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南
企业入驻日期: 2017-11-09