北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京生物工程/生物制药招聘

(Senior)Specialist, Data Management

再鼎医药(上海)有限公司

  • 公司规模:500-1000人
  • 公司性质:外资(非欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2020-12-10
  • 工作地点:上海-浦东新区
  • 招聘人数:1人
  • 工作经验:1年经验
  • 学历要求:本科
  • 职位月薪:1-2万/月
  • 职位类别:生物工程/生物制药

职位描述

?    Manage / assign responsibilities for Data Managers and also serve as a member of Study Teams. Act as primary Data Management contact and contributor for projects

?    Liaise with CROs, EDC vendors and other third-party vendors in a project-manager capacity in support of timelines and data-related deliverables.

?    Create / monitor timelines and ensures that all deadlines are met with quality

?    Participate in the review of clinical data, analysis tables, listings, figures, and patient profiles for data consistency and accuracy

?    Identify and troubleshoot operational problems and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders

?    Review and provide feedback on protocols, Statistical Analysis Plans, etc.

?    Develop and support creation of data management documentation, specifications and UAT requirements for database and test according to UAT Plan

?    Create, review and revise data management documentation

?    Ensures data management activities are conducted in accordance with GCP, GCMP, internal SOPs, and meet all regulatory requirements

?    Identify project challenges and risks, and proposing appropriate and strategic solutions to issues
职位要求:
?    BA or BS degree in a health-related field preferred
?    0-3 years of related experience in clinical data management in the Pharmaceutical, Biotechnology industry or equivalent
?    Electronic data capture experience (Medidata Rave) and working knowledge of Oncology indications
?    Proficient in data management activities including CRF and clinical database design, clinical data cleaning and analysis for Oncology trials
?    Overall understanding of ICH, GCP, CDISC and other applicable regulatory guidelines as they pertain to data management
?    Knowledge of SDTM models and experience transforming raw data into those standards
?    Knowledge of Data Management and Pharmacovigilance processes in clinical trials.
?    Knowledge and coding experience using MedDRA and Who Drug dictionaries

职能类别:生物工程/生物制药

公司介绍

Zai Lab is an innovative biopharmaceutical company based in Zhang Jiang, Shanghai focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. Zai Lab focus on innovation to meets the unmet medical needs. Zai has built up a strong pipeline with multiple programs on clinical stages. Zai Lab successfully listed on Nasdaq in Sep. 2017.

再鼎医药是一家总部设立于上海张江,致力于研究、开发和销售创新药物的制药企业。再鼎医药针对目前尚无良好治疗手段的疾病领域开发新药,在肿瘤、抗感染、自身免疫等方面建立了全面的产品线,服务中国和全球病患。再鼎医药于2017年9月在美国纳斯达克成功上市。

联系方式

  • 公司地址:地址:span上海浦东张江高科技园区金科路4560号金创大厦3号楼8楼