北京招聘

?    Manage clinical trials data or data management projects under timelines in a high quality and professional manner. Identify requirements for capture and processing of clinical data ensuring accuracy, consistency and completeness while adhering to SOPs and work guidelines as required.
?    Oversee Data Management vendors – review and approve all DM documentation; maintain all data management internal files, ensuring preparedness for regulatory inspections.
?    Lead regular data review meetings in a cross-functional team environment.
?    Participates in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities
?    Oversee the design, creation and testing of clinical study databases, responsible for creating and adhering to Data Management timelines and budget.
?    Review protocols for proper data capture including electronic Case Report Form design. Able to perform a thoroughly detailed review of eCRF data requirements. Ability to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans etc.
?    Designs and/or reviews eCRFs, annotated eCRF, eCRF completion guidelines, Data Management Plans, Data Surveillance Plan, detailing complete data management processes throughout clinical studies.
?    Create/Oversee development of data edit check specifications and manual data listings as required.
?    Responsible for data cleaning, query and resolutions, review of medical coding, database lock activities
?    Responsible for lab reconciliation, manage and reconcile external data, authoring data transfer agreements, and ensuring study documentation to be filed in the eTMF
?    Working with Safety/PV function to develops study specific Serious Adverse Event (SAE) reconciliation guidelines, reconciles SAEs, comparing events across the clinical database and drug safety database, addressing any discrepancies, as per SAE guidelines  
?    Possesses solid computer system and technical skills with a strong ability to learn multiple e computer applications. Prior experience with different Data Management systems and technologies, Electronic Data Capture systems and CDISC data standards are desirable.
?    Proficient working knowledge of any of the following strongly desired: SAS, Spotfire or other Visualization Tools, Data Standards management, SDTM
职位要求：
?    Bachelor or Master degree in a health care or related field
?    +5 years of clinical data management experience within Biopharma/CRO environment. Oncology/Immuno-Oncology experience is preferred.
?    Team player who effectively works with colleagues in clinical, clinical operation, and statistics function

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。