Data Management Manger
广州誉衡生物科技有限公司
- 公司规模:150-500人
- 公司性质:民营公司
- 公司行业:制药/生物工程
职位信息
- 发布日期:2019-10-23
- 工作地点:北京-顺义区
- 招聘人数:若干人
- 工作经验:无工作经验
- 学历要求:招若干人
- 语言要求:不限
- 职位月薪:2-2.5万/月
- 职位类别:临床研究员
职位描述
? Responsible for ensuring the completeness quality and integrity of the subject data in the clinical trial database
? Responsible for data management activities within a clinical trial according to regulations applicable Standard Operating Procedures (SOPs) and Processes
? understanding key processes and principles associated with role including CRF design, database set-up, edit check specification, DMP and data cleaning activities.
? Review protocols to ensure the data collection, database and reporting requirements can be met and are standardized across the program
? Accountable for the implementation of data activities including Study Startup, Data Acquisition, Standards and Discrepancy Management for the responsible studies.
? Reconcile the patient database with the Serious Adverse Event database
? Document all efforts of data management and file all responsible documents
? Works independently receives instruction primarily on unusual situations
? Ability to organize multitasks prioritize and deliver on time
? Ability to communicate effectively and appropriately with internal external stakeholders
Qualifications
? Bachelor’s degree or equivalent in a natural/medical science data management or related discipline
? Demonstrated basic knowledge of data management processes and principles in area of responsibility
? Demonstrated basic knowledge of Windows Environment and its applications (Word Excel PowerPoint Project etc.)
? 3-5years of data management experiences
? Demonstrated good English comprehension skills both reading and writing
职能类别:临床研究员
公司介绍
誉衡生物秉承开放、合作的核心价值观,立足国内放眼全球,聚焦肿瘤药物的研发、生产与销售。誉衡生物***个商业化药品——基于全球领先的抗体研发技术平台开发的新型全人源抗PD-1单抗,赛帕利单抗注射液(誉妥®),其***获批适应症为复发或难治性经典型霍奇金淋巴瘤,在II期临床研究中,经研究者评估有效率高达92.86%,将惠及淋巴瘤患者的长期生存。
遵循ICH和GxP的规范,整合利用经广泛认证的先进技术平台和符合GMP要求的生物药生产线,与国内外合作伙伴通力合作开发最前沿的生物医药产品,提高用药可及性,降低患者的用药负担是誉衡生物一直以来坚守的初心和使命。后续,LAG-3等系列前景广阔的单双抗药品在陆续布局与开发中,誉衡生物将以患者为中心,以科学为基础,为健康中国,为全球医生和患者供创新、安全、有效的解决方案,未来可期!
联系方式
- 公司地址:江岸区