天津招聘

Job Summary:
Frontage is seeking Clinical Data Manager(s) to join our China Biometrics operation in Shanghai or Beijing office. Incumbent manages the design, development, modification, and evaluation of systems for collecting and organizing clinical study data to identify, analyze, and report data and trends. Including but not limited to the development and design of case report forms; development of clinical data management plans; identifies and resolves data anomalies; over sees data validation efforts; interacts with project management staff to assure compliance with project timelines and deliverables.
Major Responsibilities:
1. Leads study setup activities including CRF, data management plan and database design
2. Performs routine data management and analysis activities
3. Identifies, investigates, and resolves data anomalies and discrepancies
4. Reviews data output and distributes data summaries
5. Oversees the design, validation efforts and documentation of clinical data system and statistical analysis methods.
6. Ensures data management methods, equipment, and practices are in compliance with FDA regulations, GCP guidelines, and internal SOPs
7. Interfaces with clients to assess data management needs and deliverables
8. Basic SAS programming for data mapping desirable

Qualifications:
1. Requires excellent written and oral communication skills
2. Requires a BS or MS in a data related fields and/or health care field (e.g., nursing, pharmacy, physician's assistant)
3. Minimum of 5 years' work experience in the clinical research industry with 3 years' experience in clinical data management for a contract research organization (CRO)
4. Experienced with operations of clinical data management systems and Oracle Clinical Database
5. Knowledgeable in all aspects of the Federal (FDA) regulations and requirements governing the conduct of clinical trials including, but not limited to, GCP and ICH requirements
6. Familiarity with SAS programming or SQL query preferred
7. Strong clinical data knowledge and medical terminology
8. Strong work knowledge in Paper-based systems and Electronic Data Capturing Systems

方达医药全球型全方位新药研发外包服务公司（CRO）,于2001年成立于美国，总部位于宾夕法尼亚州费城西郊的埃克斯顿。2006年成立方达医药技术（上海）有限公司，在苏州和郑州分别设有分公司和管理团队。2019年5月30日，方达控股（方达医药上市主体）成功登陆香港联交所主板，股票代码*******。

方达医药始终坚持“中美两国，同一质量体系”准则，获得数据可用于全球申报，目前已为全球400多家客户提供高质量、高标准的新药和仿制药研发服务。作为中国制药企业国际化及高端药物研发合作伙伴，方达医药拥有技术熟练的专业团队，配备了国际最先进的药物研发仪器和设备，并努力为客户创造友好轻松的合作和沟通环境。专注于一体化的专业服务，业务范围包括生物分析、BE临床服务、CMC药品制剂研发、cGMP咨询及国际药品注册等服务项目。

● 我们为员工提供全面的福利待遇，并履行对员工健康和福利的全面承诺。
● 我们为员工提供了与***制药公司合作的机会，让其成为药物开发过程的关键贡献者。
● 我们为员工提供良好的职业发展机会，确保员工在行业内不断积累经验。
● 我们的员工是最有价值的资产，我们拥有明确的员工奖赏计划，肯定员工的奉献精神，奖励员工的辛勤付出。

您也可以发送简历至招聘邮箱：recruitment@frontagelab.com.cn
更多信息请浏览公司网站：**********************