上海招聘

1. 职位描述：
1) 与客户数据管理部门沟通协调
2) CRF设计
3) 数据库的创建、维护、备份与恢复
4) 撰写数据管理计划
5) 撰写数据核查计划及编程
6) 注释CRF、原始数据库以及衍生SAS数据库说明，构建并验证数据库。
7) 指导数据录入，保证数据质量
8) 负责数据核查、修改、跟踪
9) 数据质疑表管理
10) 负责数据库质量审查
11) 负责数据医学编码
12) SAE一致性核查
13) 撰写数据管理报告


2. 职位要求：
1) 流行病学、生物统计学、医学或相关专业本科或以上学历
2) 2年以上数据管理工作经验，有临床试验工作经验者优先
3) 了解ICH-GCP等临床试验指南
4) 熟悉SAS编程语言及SQL语言
5) 良好数据库基础，熟悉ORACLE等数据库管理软件
6) 熟悉视窗操作系统及其应用程序（如Word、Excel、PowerPoint及Access等）
7) 良好的中文、英文书面及口头表达能力
8) 良好的沟通、协调能力，具有团队精神
1. Job Description:
1) Communication with sponsor on Data management
2) CRF design
3) Database creation, maintenance, backup and recovery
4) Data management plan development
5) CRF annotation, database description and database construct/validation
6) Data entry instruction and training, assurance in quality of data entry
7) Data validation, update and audit trial
8) Query management
9) Data quality control
10) Medical coding
11) SAE reconciliation
12) Data management report

2. Requirement:
1) Bachelor degree or equivalent in epidemiology, biostatistics, medical science or related discipline
2) Two years of previous experience within a data management role, working experience in clinical trials is desirable;
3) Familiar with ICH-GCP
4) Familiar with SAS programming and SQL language
5) Working knowledge of database and familiar with Oracle database software;
6) Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint and Access)
7) Capability to communicate effectively in English, both verbally and written
8) Strong communication and coordination skills, work as a team player

上海盛特尼医药科技有限公司是一家主要从事卫生经济和医疗咨询服务的公司，由一群顶尖的行业专家包括卫生经济学家、结果研究专家、临床医师、政策法规和安全/风险管理专家等创立。

上海盛特尼医药科技咨询公司为全球制药和医疗器械企业的产品提供整个生命周期的管理和咨询，其中包括：卫生经济、卫生技术评估，法规事务，市场切入，临床试验、数据管理及统计分析和风险管理解决方案。

上海盛特尼医药科技的专业团队熟知亚洲、美国、欧洲以及其他新兴市场的医疗卫生体系，同时，我们与世界其他卫生经济咨询公司的密切合作也使得公司不断拓展全球业务。
我们的服务覆盖产品生命周期的每一个阶段，包括：
1. 对药品上市前的临床和结果评价
2. 注册及国际多中心临床试验申请的递交
3. I-IV 四期临床试验的管理
4. II/III期临床试验中病例报告结果以及经济学研究的设计，执行，分析以及报告
5. 建立卫生经济模型
6. 为定价决策提供支持
7. 为满足市场切入的要求制定相关策略
8. 根据国家要求，准备卫生技术评估及卫生结果价值材料（ health outcomes value dossiers ）；
9. 上市后市场切入策略的制定以及交流工具开发
10. 制定政策法规和风险管理战略计划

除了核心科学团队，我们有一个由世界知名的行业专家组成的国际顾问委员会，他们的专业涵盖卫生经济，生物统计，政策研究，市场切入/ 卫生技术评估等。 在需要的时候，他们可随时提供帮助支持。

对于每一个项目，无论它涉及卫生经济，系统综述，卫生技术评估，法规事务还是市场切入，“知识、创新、智慧”都是盛特尼不变的追求。

上海盛特尼医药科技主要业务包括：
卫生技术评估；
结果研究；
市场切入；
定价；
报销研究；
临床试验、数据管理及统计分析；
法规事务；
安全与风险评估

Shanghai Centennial Scientific Ltd. is a premium health economic and health care consulting company in China established by top specialists including health economicists, outcomes researchers, statisticians, clinicians, regulatory and safety/risk management professionals.

Shanghai Centennial Scientific offers professional consulting services throughout the product lifecycle. We delivers health economic, HTA, regulatory affairs, market access,clinical trial and data management, and risk management solutions to global and local pharmaceutical/medical device companies.

Shanghai Centennial Scientific’s highly specialized team consists of top experts in health economists, market access, regulatory, medical writing, clinical and safety data management, as well as database and multimedia experts. Our scientific team has a through understanding of Asia, US, European and other emerging market health care systems. The company is also closely connected with other global health economic companies to facilitate our global presence.

In addition to our core scientific team, we have an affiliated international scientific board comprised with a group of globally recognized experts in the area of health economics, biostatistics, policy research, market access/HTA, and graphics designing to support us on an as-needed basis

Shanghai Centennial Scientific bring knowledge, creativity and intellect to every project we undertake whether it is health economics, systematic review, HTA, regulatory affairs, safety accessment, or market access.
Shanghai Centennial Scientific’s key deliverables include:
1.Health technology Assessment
2.Outcomes Researches
3.Market Access
4.Pricing
5.Reimbursement Research
6.Clinical trial and data management
7.Regulatory affairs
8.Safety and risk management

Our services have evolved over time to meet the increasing need for health economic, evidence based solutions, clinical data management, regulatory and risk management; our vast experience across a wide range of disease areas is second to none.

We provide services at every stage of the product lifecycle including:
1.Pre-launch evaluations of disease burden and outcome evidence
2.Registration or global trial submission
3.Phase I-IV clinical trial management
4.Phase II/III patient reported outcomes and economic study design, conduct, analysis, and report
5.Development of comprehensive health economic models
6.Input into pricing decisions and develop strategy to meet market access requirements
7.Preparation of HTA and health outcomes value dossiers according to country requirement
8.Development of post-launch access strategy and communication tools
9.Develop regulatory and risk management strategic plan