Description
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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.
Generate, resolve, and track queries to address problematic data identified during data review activities.
Apply quality control procedures and checks to ensure data quality standards (client and Fortrea) are achieved.
Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRF Completion guidelines, Data Management Plans. Perform Data review utilizing all applicable documents such as protocols, CRFs (or eCRFs and eDiary) 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.
Create and assist in the data review guidelines, make sure to be consistent with the clinical data model, 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.
May assist with the Lead Data Manager or Lead Data Reviewer to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team, as necessary.
Inform Lead Data Reviewer of overages in budgeted units and assist in Change Order Log process, if applicable
Perform quality control on data management activities as appropriate to include, but not be limited to all study documentation, query generation and integration; to ensure that internal and client quality standards are achieved.
Support and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team, as appropriate.
Mentor / Coach in training of project staff on project-specific, global, standardized data management processes.”
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact
