Sr. Clinical Research Associate
赛生贸易（上海）有限公司
- 公司规模：500-1000人
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2012-08-08
- 工作地点：北京
- 招聘人数：1
- 工作经验：二年以上
- 学历要求：本科
- 语言要求：英语精通
- 职位类别：临床协调员
职位描述
Job Title: Sr. Clinical Research Associate
Department: Medical & Regulatory
Report To: Director, Medical & Regulatory
Duties and Responsibilities
? Clinical operation
? Prepare, perform, coordinate and oversea all respects of the clinical study
- Bear sound awareness of GCP, ICH.
- Participate in pre-study preparation including protocol/CRF/ICF/diary card development, PSV, PI/site selection, CRO training and so on
- Prepare the study administrative issues such as material printing, labeling & packaging and other logistic affairs Assistant the organization of Investigators' Meetingwith invitation, accommodation, transportation, presentation, meeting minutes writing and other administrative affairs
- Prepare and submit EC documents to IRBs Conduct study Initiation organization
- Conduct co-monitoring visits, close-out visits
- Coordinate with outsourcing CRAs to follow up the auditing results, to sort out remaining problems
- Perform regular communication with CRO to review project progress and solve problems occurred in the study, as well as to draft meeting minutes and follow the cases up
? Medical science
- Assist to write study protocol and clinical study report
- Prepare clinical overview/reports to SFDA regulatory office for pipeline products
- Medical support for sales/marketing dept. for marketed products
- Marketing research for potential product in China
? Take care of Pharmacovigilance affairs
- Collect, archive and report (severe) adverse event information to domestic and foreign partners/Chinese Regulatory Authority within timeline
- Collect and submit serious adverse event in a timely manner to SFDA
- Give training for SAE reporting procedure on New Employee Orientation quarterly
Qualifications
- Bachelor degree or above properly at medical or pharmacy.
- More than two years' experience in clinical practices including site management and or project management.
- Familiar with Chinese GCP and related guidelines.
- Proficiency in Basic Microsoft Word and Excel and familiarity with use of database.
- Knowledge of clinical trial methodology.
- Result oriented.
- Customer focus and teamwork.
- Organizational commitment.
- Good communication skill.
- Good at English writing and speaking
Department: Medical & Regulatory
Report To: Director, Medical & Regulatory
Duties and Responsibilities
? Clinical operation
? Prepare, perform, coordinate and oversea all respects of the clinical study
- Bear sound awareness of GCP, ICH.
- Participate in pre-study preparation including protocol/CRF/ICF/diary card development, PSV, PI/site selection, CRO training and so on
- Prepare the study administrative issues such as material printing, labeling & packaging and other logistic affairs Assistant the organization of Investigators' Meetingwith invitation, accommodation, transportation, presentation, meeting minutes writing and other administrative affairs
- Prepare and submit EC documents to IRBs Conduct study Initiation organization
- Conduct co-monitoring visits, close-out visits
- Coordinate with outsourcing CRAs to follow up the auditing results, to sort out remaining problems
- Perform regular communication with CRO to review project progress and solve problems occurred in the study, as well as to draft meeting minutes and follow the cases up
? Medical science
- Assist to write study protocol and clinical study report
- Prepare clinical overview/reports to SFDA regulatory office for pipeline products
- Medical support for sales/marketing dept. for marketed products
- Marketing research for potential product in China
? Take care of Pharmacovigilance affairs
- Collect, archive and report (severe) adverse event information to domestic and foreign partners/Chinese Regulatory Authority within timeline
- Collect and submit serious adverse event in a timely manner to SFDA
- Give training for SAE reporting procedure on New Employee Orientation quarterly
Qualifications
- Bachelor degree or above properly at medical or pharmacy.
- More than two years' experience in clinical practices including site management and or project management.
- Familiar with Chinese GCP and related guidelines.
- Proficiency in Basic Microsoft Word and Excel and familiarity with use of database.
- Knowledge of clinical trial methodology.
- Result oriented.
- Customer focus and teamwork.
- Organizational commitment.
- Good communication skill.
- Good at English writing and speaking
公司介绍
公司介绍
赛生公司成立于1992年，总部设于美国加利福尼亚州旧金山市。我们公司是一家以销售为驱动、效益好的、以中国为中心的特种医药公司，公司拥有大量的国际业务和癌症及传染性疾病的新疗法的产品组合。我们提供高质量的、在西方生产的针对某些致命的疾病的药物治疗，特别专注于癌症和严重的传染性疾病。
在中国。自从1996年引进中国以来,市场上的成功有赖于我们员工的共同努力，有赖于我们的企业文化和充份发挥团队精神的结果。您的加入无疑是在我们前进中增添了一股新的力量。
诺凡麦医药成立于2005年，她立足于中国，专业从事制药行业。公司以国际风险投资和私人投资为主，具有雄厚的资金来源。并通过国际化商业运作方式，与欧洲和日本等国的合作伙伴都建立了战略联盟。
诺凡麦致力于打造中国首家虚拟整合的制药集团。公司具有完备的商业职能，包括销售和市场、注册、流通、生产以及研发等。公司的创始人均为前跨国制药公司高层管理人员。他们具有在中国及国际医药行业的良好业绩表现，充分理解中国医药市场，具有丰富的工作经验和广泛的人际网络。
2011年初，赛生公司收购了诺凡麦公司，从此，赛生与诺凡麦公司合并成为一个统一的公司。公司分别于北京、上海、广州、杭州、南京、重庆、天津、沈阳、乌鲁木齐等多地设立分公司或者办事处，目前在中国员工已经超过700人。赛生诺凡麦公司拥有以下核心竞争力：创新商业模式；国际运作结合本土优势；全球风险投资雄厚资金保障；优秀的团队卓越执行力。
现在，公司销售区域持续扩张，新的机遇再次出现！如果你有信念，有热情，有对成功的渴望，有迎接真正挑战的决心，有不断学习的意愿，那么请你来加入我们吧，我们将帮助你成功！
加入赛生诺凡麦公司，成就你和我的未来，一起为建设美好健康新世界而努力！
Company Introduction
SciClone Pharmaceuticals was founded in 1992, headquartered in San Francisco, California. Our company is a sales driven, revenue-generating and China-centric, specialty pharmaceutical company. The company has a substantial international business and new therapy portfolio of products for cancer and infectious diseases. We provide high quality medication for some deadly disease which prouced in the west , especially focus on cancer and serious infectious disease.
In China, ZADAXIN Introduced in China since 1996, Success in the market depends on the support of our staff, rely on our enterprise culture and the maximum utilization of the team spirit. There is no doubt that your join will make us fresh life in progress
Founded in 2005，NovaMed Pharmaceuticals is a leading China-focused specialty pharmaceutical company. The company is mainly backed by international venture capital and private investment , with strong source of funding. And through the international business works, The campany has established the strategic alliance with Europe and Japan and other Partner Countries
Novamed devotes in makes one “China first virtual integrated pharmaceutical group”. The company has perfect commercial functions, including sales and market, registered, circulation, production and development, etc. The founders of the company are former top executive comes from multinational pharmaceutical companies . They have good performance in China and international pharmaceutical industry , In the meantime they fully understand Chinese medicine market, and has the rich work experience and a wide network of relationships.
In early 2011, SciClone Pharmaceuticals Inc acquired Novamed Pharmaceuticals Inc, From then on, the two company Merged with a unified company. The company establish subsidiary companies or offices in Beijing, Shanghai, guangzhou, hangzhou, nanjing, chongqing, tianjin, shenyang, wulumuqi and so on，At present there are more than 700 employees in China ，The company has the following core competitiveness ：innovative business model；international operation combined with local advantage；global venture capital ；financial strength；excellent team and execution .
Now, the company continue to expand sales area and new opportunities appear again！If you have faith and passion, with the desire for success，willing to take challenges and never cease learning，Pls join us，We will help you success.
To join our company, creates our future. Let’s try our best to build a new and better world.
希望了解更多关于赛生诺凡麦，请登录公司主页：http://www.sciclone.com
如何联系我们：
如是和日达仙相关产品的职位，请联系：
赛生贸易（上海）有限公司
邮箱：HRChina@sciclone.com
如是和诺凡麦相关产品的职位，请联系：
诺凡麦医药贸易（上海）有限公司
邮箱：hr.recruitment@novamed.com.cn
赛生公司成立于1992年，总部设于美国加利福尼亚州旧金山市。我们公司是一家以销售为驱动、效益好的、以中国为中心的特种医药公司，公司拥有大量的国际业务和癌症及传染性疾病的新疗法的产品组合。我们提供高质量的、在西方生产的针对某些致命的疾病的药物治疗，特别专注于癌症和严重的传染性疾病。
在中国。自从1996年引进中国以来,市场上的成功有赖于我们员工的共同努力，有赖于我们的企业文化和充份发挥团队精神的结果。您的加入无疑是在我们前进中增添了一股新的力量。
诺凡麦医药成立于2005年，她立足于中国，专业从事制药行业。公司以国际风险投资和私人投资为主，具有雄厚的资金来源。并通过国际化商业运作方式，与欧洲和日本等国的合作伙伴都建立了战略联盟。
诺凡麦致力于打造中国首家虚拟整合的制药集团。公司具有完备的商业职能，包括销售和市场、注册、流通、生产以及研发等。公司的创始人均为前跨国制药公司高层管理人员。他们具有在中国及国际医药行业的良好业绩表现，充分理解中国医药市场，具有丰富的工作经验和广泛的人际网络。
2011年初，赛生公司收购了诺凡麦公司，从此，赛生与诺凡麦公司合并成为一个统一的公司。公司分别于北京、上海、广州、杭州、南京、重庆、天津、沈阳、乌鲁木齐等多地设立分公司或者办事处，目前在中国员工已经超过700人。赛生诺凡麦公司拥有以下核心竞争力：创新商业模式；国际运作结合本土优势；全球风险投资雄厚资金保障；优秀的团队卓越执行力。
现在，公司销售区域持续扩张，新的机遇再次出现！如果你有信念，有热情，有对成功的渴望，有迎接真正挑战的决心，有不断学习的意愿，那么请你来加入我们吧，我们将帮助你成功！
加入赛生诺凡麦公司，成就你和我的未来，一起为建设美好健康新世界而努力！
Company Introduction
SciClone Pharmaceuticals was founded in 1992, headquartered in San Francisco, California. Our company is a sales driven, revenue-generating and China-centric, specialty pharmaceutical company. The company has a substantial international business and new therapy portfolio of products for cancer and infectious diseases. We provide high quality medication for some deadly disease which prouced in the west , especially focus on cancer and serious infectious disease.
In China, ZADAXIN Introduced in China since 1996, Success in the market depends on the support of our staff, rely on our enterprise culture and the maximum utilization of the team spirit. There is no doubt that your join will make us fresh life in progress
Founded in 2005，NovaMed Pharmaceuticals is a leading China-focused specialty pharmaceutical company. The company is mainly backed by international venture capital and private investment , with strong source of funding. And through the international business works, The campany has established the strategic alliance with Europe and Japan and other Partner Countries
Novamed devotes in makes one “China first virtual integrated pharmaceutical group”. The company has perfect commercial functions, including sales and market, registered, circulation, production and development, etc. The founders of the company are former top executive comes from multinational pharmaceutical companies . They have good performance in China and international pharmaceutical industry , In the meantime they fully understand Chinese medicine market, and has the rich work experience and a wide network of relationships.
In early 2011, SciClone Pharmaceuticals Inc acquired Novamed Pharmaceuticals Inc, From then on, the two company Merged with a unified company. The company establish subsidiary companies or offices in Beijing, Shanghai, guangzhou, hangzhou, nanjing, chongqing, tianjin, shenyang, wulumuqi and so on，At present there are more than 700 employees in China ，The company has the following core competitiveness ：innovative business model；international operation combined with local advantage；global venture capital ；financial strength；excellent team and execution .
Now, the company continue to expand sales area and new opportunities appear again！If you have faith and passion, with the desire for success，willing to take challenges and never cease learning，Pls join us，We will help you success.
To join our company, creates our future. Let’s try our best to build a new and better world.
希望了解更多关于赛生诺凡麦，请登录公司主页：http://www.sciclone.com
如何联系我们：
如是和日达仙相关产品的职位，请联系：
赛生贸易（上海）有限公司
邮箱：HRChina@sciclone.com
如是和诺凡麦相关产品的职位，请联系：
诺凡麦医药贸易（上海）有限公司
邮箱：hr.recruitment@novamed.com.cn
联系方式
- 公司网站：http://www.sciclone.com
- Email：HRChina@sciclone.com
- 公司地址：上海市淮海中路93号大上海时代广场2904-10室&30楼
- 邮政编码：200021