Clinical Data Coordinator (临床数据管理)
- 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
More than 1year Related experiences
职能类别:生物工程/生物制药临床数据分析员
关键字:CDCClinicalData临床数据生物制药covance
联系方式
上班地址:大连腾飞园区5号楼
公司信息
At Covance, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.
We Offer
Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
There is no better time to join us!
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