Trial Project Data Manager
默沙东(研发)中国有限公司
- 公司性质:合资
- 公司行业:制药/生物工程
职位信息
- 发布日期:2022-07-27
- 工作地点:北京-朝阳区
- 工作经验:5-7年经验
- 学历要求:本科
- 职位月薪:25-40万/年
- 职位类别:生物工程/生物制药
职位描述
Primary Activities
1. Develops detailed project plans for the collection, review, and cleaning of all clinical data for assigned trials within a specific drug / vaccine program.
Data includes, but is not limited to, case report form (CRF) data, lab data, biomarker data, and patient reported outcomes.
2. Serves as project manager of all clinical data management activities for trials as assigned. Under the guidance of more senior staff when appropriate, uses excellent interpersonal, negotiating, and project management skills to perform and manage the tasks.
3. Defines trial-level requirements for quality data collection and validation at the trial level.
4. Manages trial-level data quality and completion of database lock and post-database lock activities.
5. Accountable for ensuring the successful execution of delivery of data management services provided by external partners engaged for outsourced trials.
6. Supports site and sponsor audits, as appropriate.
7. Identifies and supports improvements to data collection and data management processes and tools.
Education:
At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.
Experience: At least 3 years’ experience in Clinical Data Management with at least 1 year experience working with formal project management tools and processes. Extensive start-up and in-life data management experience is required.
Knowledge and Skills:
? Understanding of the clinical research process with in-depth knowledge of the Clinical Data Management lifecycle.
? Familiar and comfortable with database concepts and tools to manage, extract, and report data.
? Knowledge of applicable regulations and policies.
? Strong organization and management skills.
? Demonstrated excellent project management and leadership skills.Ability to coordinate the work of others and influence decision making.
? Must be able to communicate effectively — orally and in written form — with technical and business areas.
1. Develops detailed project plans for the collection, review, and cleaning of all clinical data for assigned trials within a specific drug / vaccine program.
Data includes, but is not limited to, case report form (CRF) data, lab data, biomarker data, and patient reported outcomes.
2. Serves as project manager of all clinical data management activities for trials as assigned. Under the guidance of more senior staff when appropriate, uses excellent interpersonal, negotiating, and project management skills to perform and manage the tasks.
3. Defines trial-level requirements for quality data collection and validation at the trial level.
4. Manages trial-level data quality and completion of database lock and post-database lock activities.
5. Accountable for ensuring the successful execution of delivery of data management services provided by external partners engaged for outsourced trials.
6. Supports site and sponsor audits, as appropriate.
7. Identifies and supports improvements to data collection and data management processes and tools.
Education:
At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.
Experience: At least 3 years’ experience in Clinical Data Management with at least 1 year experience working with formal project management tools and processes. Extensive start-up and in-life data management experience is required.
Knowledge and Skills:
? Understanding of the clinical research process with in-depth knowledge of the Clinical Data Management lifecycle.
? Familiar and comfortable with database concepts and tools to manage, extract, and report data.
? Knowledge of applicable regulations and policies.
? Strong organization and management skills.
? Demonstrated excellent project management and leadership skills.Ability to coordinate the work of others and influence decision making.
? Must be able to communicate effectively — orally and in written form — with technical and business areas.
公司介绍
默沙东(研发)中国有限公司诚聘
联系方式
- 公司地址:上海市徐汇区古美路1582号