Sr. Clinical Data Specialist Full-time Job

Review clinical trial data in accordance with 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 suppott 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.

Perfonn reconciliation of the clinical and safety databases.

Perform reconciliation of central laboratory and / or third party vendor data (eCRF, edDiary, specialty laboratory, etc.),

Perf01m 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 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, analysis plans, and CRF (eCFR) 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.

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