Covance

Assist Clinical Data Manager

Job Location(s) CN-Dalian
Job Number
2021-63204
Job Category
Clinical Data Management
Position Type
Full-Time
Telecommute
No

Job Overview

• 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
• 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
• 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
• Serve as client contact for project meetings and CDM status updates
• Potentially support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
• Support the training of project staff on project-specific, global, standardized data management processes
• Maintain technical data management competencies via participation in internal and external training seminars
• Review literature and research technologies/procedures for improving global data management practices
• Perform other duties as assigned by management

Education/Qualifications

Bachelar or above

Experience

More than 4 years DM experiences

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