Job Overview
Participate as the primary data management representative on the client's multidisciplinary project teams and ensure effective communication exchange.
Essential Functions
* 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
Qualifications:
* 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. RN, MT, PA, RT) is preferred, but individuals with commensurate experience will be considered.
* Experience with Electronic Data Capture (EDC) system(s) is required.
* Experience with Oracle Inc.'s Inform EDC system is preferred.
* Oncology and/or inflammatory therapeutic area experience is preferred.
* Project management experience (within Data Management) is preferred.
* Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is preferred.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
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