上海招聘

职位描述：
Clinical Data Coordinator

*Responsibilities/Duties
Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data
Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data
Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database
Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application
Perform reconciliation of the clinical and safety databases
Perform reconciliation of central laboratory and/or third party vendor data (eCRF, eDiary, specialty laboratory, etc.)
Perform aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, etc.), and/or data inconsistencies that require further investigation
Apply quality control procedures and checks to ensure data quality standards (client and Covance) are achieved
Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRFs and eDiary), monitoring conventions, CRF (eCRF) completion guidelines, etc.
Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data
Assist in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications
Assist in the creation of data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions
Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities
Potentially interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality
Potentially serve as client contact for project meetings and CDM status updates
Support the training of project staff on project-specific, global, standardized data management processes
Perform other duties as assigned by management.

*Education/Qualifications
Bachelor and above

*Experience
2-3 years 举报 分享

LabCorp是全球顶尖的生命科学公司，科文斯作为LabCorp旗下的药物研发部门，肩负着改善人类健康与生命的共同使命。科文斯的实验室和设施遍布全球，在世界范围内拥有超过26000名员工，卓越的研发能力和强大的人才资源奠定科文斯在医药研发行业的领先地位。截止到2020年，科文斯中国团队共参与了近100个获得上市许可的新药研发，积极支持超过50个免疫肿瘤药物的研发项目，是服务***面的药物研发公司。

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