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Responsibilities
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, with with highest achievable quality.Summary of the Essential Functions of the JobParticipate as the primary data management representative on multidisciplinary project teams and ensure effective communication exchange.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 RequirementsMinimum of 5 years of data management experienceBachelor'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.Oracle Inform EDC experienceOncology and/or inflammatory therapeutic area experience is preferred.Project management experience (within Data Management) is preferred.CRO or Pharma data management experienceThis role is not eligible for UK visa sponsorshipIQVIA 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.comWhere you'll workHome-basedYou’ll work remotely, with the flexibility to do your best work from home. Supported by collaborative tools and a global team, you’ll stay connected while enjoying the autonomy and balance that comes with a fully remote role.CultureCulture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care — about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.
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