Sr Clinical Data Specialist

<h2>Job Overview:</h2><p style="margin: 0px;">Review clinical trial data in accordance with [Global] Data Management Plans and <br />applicable standardized data management processes (SOPs, Work Instructions, etc.) to <br />identify erroneous, missing, incomplete, or implausible data.<br />• Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy <br />listings) used to support the review of clinical trial data.<br />• Generate, resolve and track queries to address problematic data identified during data <br />review activities.<br />• Perform aggregate review of clinical data by patient, site and / or project to identify <br />data trends (patient safety, compliance, etc.) and / or data inconsistencies that require <br />further investigation.<br />• Apply quality control procedures and checks to ensure data quality standards (client <br />and Covance) are achieved.<br />• Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRF<br />Completion guidelines, Data Management Plans, Perform Data review utilizing all <br />applicable documents such as protocols, CRFs (or eCRFs and eDiary) etc.<br />• Assist with the development of [Global] Data Management Plans and Quality <br />Management (QM) Plans that will deliver accurate, timely, consistent, and quality <br />clinical data.<br />• Assist in the review of the database design and annotate the CRF (eCRF) according to <br />the specifications.<br />• Create and assist in the data review guidelines, make sure to be consistent with the <br />clinical data model, and CRF/eCRF completion / monitoring conventions.<br />• Assist in the development and testing of data management system edit / data validation <br />checks (diagnostics) and special listings / procedures used as tools for the data review <br />and discrepancy management activities.<br />• May assist with the Lead Data Manager or Lead Data Reviewer to build timelines to <br />meet contracted milestones by communicating with leads in different disciplines and <br />the full project team as necessary.<br />• Knowledge of Data Management tools, systems, and processes. <br />• Ensures service and quality, meet agreed upon specifications per the DMP and scope of <br />work in the budget.<br />• Inform Lead Data Reviewer of overages in budgeted units and assist in Change Order <br />Log process, if applicable</p><h2>Education/Qualifications:</h2><p style="margin: 0px;">University / college degree (life sciences, health sciences, information technology or <br />related subjects preferred). <br />Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree</p><h2>Experience:</h2><p style="margin: 0px;">4 to 6 years of Clinical Data Management.<br />• Some knowledge of clinical trial process, DM, clinical operations, biometrics, and system <br />applications to support operations. <br />• Time management skill and ability to adhere to project productivity metrics and timelines.<br />• Ability to work in a team environment and collaborate with peers.<br />• Good organizational ability, communication, and interpersonal skills.<br />• Team working skills and good collaborator skills.<br />• Knowledge of medical terminology is preferred.<br />• Knowledge of science or a scientific background is preferred.<br />• Good oral and written communication skills.</p>