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IQVIA
Clinical Data Manager
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What they do
A Clinical Data Manager manages data and information gathered for a clinical trial to study of medical treatments or drugs. Assists with developing tools used for data collection, manages all aspects of data collection and validation during a clinical trial, and oversees the closeout of a trial and transfer of data for statistical analysis.
$116,209 / year median in North Carolina
Job Description
Job Summary The Clinical Data Manager performs activities pertaining to the conduct of Phase I-III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines. The CDM ensures, from a data management perspective, assigned trials on time, within budget, and with highest achievable quality. Summary of the Essential Functions of the Job Responsible for communicating key clinical data management metrics (e.g., data entry status, query resolution and aging, etc.) and determining appropriate actions in conjunction with study team. Responsible for the review, development and/or writing of clinical trial documents and manuals, including but not limited to Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans and eCRF Completion Guidelines. Participate in User Acceptance Testing (UAT), as needed. Participate in Quality Control (QC), as needed. Responsible for working with the assigned Clinical Database Programmer(s) to ensure the development of the Data Flow Chart(s), Data Transfer Specifications and Import Guidelines. Assist with site and/or third party vendor training on CDM-related topics. Responsible for providing data review training and guidance to Sr. Clinical Data Coordinators that are supporting their trial(s). Perform data review and discrepancy resolution, as needed. Responsible for archiving trial(s) and associated documentation upon trial(s) completion. Ensure adherence to Good Clinical Practice and all applicable local and international regulations. Minimum Requirements Minimum of 5 years of data management experience is required. Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e.