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Clinical Data Manager, II

Utah

Clinical Data Manager, II Job Summary This position is primarily a study lead Clinical Data Manager. Itsupports multiple clinical study teams by reviewing and/orcompleting study related clinical data management deliverables.Frequently interacts with study team members to troubleshoot,manage, and develop study specific processes. Actively participatesin the development of processes, and documents, that support theclinical data management team. Huntsman Cancer Institute is committed to cancer prevention,care, and survivorship for all communities within the area we serve– which includes Idaho, Montana, Nevada, Utah, and Wyoming – withimpact worldwide. In your cover letter or during your interview process, weinvite you to share how your professional experiences have preparedyou to serve as a member of our team as we work to reduce thecancer burden experienced by all people and communities. This mayinclude description of your prior experiences related to research,prevention, clinical care, community engagement/outreach, training,administration, or other areas relevant to Huntsman CancerInstitute's mission and this position. Learn more about the great benefits of working forUniversity of Utah: benefits.utah.edu The department may choose to hire at any of the below joblevels and associated pay rates based on their business need andbudget. Responsibilities This position is patient-sensitive and must fulfill all associatedrequirements. We protect our patients, coworkers and community byrequiring all patient-sensitive employees to be immunized accordingto CDC standards and hospital policy. Limited exemptions may bemade for documented medical contraindications or religious beliefsthat object to vaccinations. Applicants must demonstrate the potential ability to perform theessential functions of the job as outlined in the positiondescription. DisclaimerThis job description has been designed to indicate thegeneral nature and level of work performed by employees within thisclassification. It is not designed to contain or be interpreted asa comprehensive inventory of all duties, responsibilities andqualifications required of employees assigned to the job. Participate in the cross-functional project teams as the leadclinical data manager. Provide input in the design of protocols, forms, and datacollection processes. Create and maintain the following study specific documents: Data Management Plans Edit specifications SAE Reconciliation Guidelines Other plans and guidelines as required Ensure documents are provided according to establishedtimelines and SOPs. Communicate issues that affect timeline, deliverables, and/ordata quality to the study team and functional supervisor. Manage and document the study specific change control processand provide realistic feedback to the study team about impact ofproposed changes. Review and provide feedback on other study specificdocuments. Manage all data management activities of a clinical trial inthe maintenance phase of the project. Provide project specific training on electronic data capture(EDC) and other data management systems to internal and externalpersonnel. Problem Solving Employees in this position arerequired to discuss questions and suggestion for improvements withthe study team prior to implementing new or modified study specificprocesses. The Clinical Data Manager II is expected to have a solidunderstanding of the regulatory framework as it relates to clinicalresearch and data management, and be able to assess current andproposed processes for compliance with regulations andstandards. Comments This position is intended to be focused onstudy level activities with oversight from the manager of clinicaldata management. Employees are expected to be the independentrepresentative of the clinical data management function on thecross functional study team. Work Environment and Level of Frequency typicallyrequired Nearly Continuously: Office environment. Physical Requirements and Level of Frequency that may berequired Nearly Continuously: Sitting, hearing, listening,talking.Often: Repetitive hand motion (such as typing),walking.Seldom: Bending, reaching overhead. Minimum Qualifications EQUIVALENCY STATEMENT: 1 year of higher educationcan be substituted for 1 year of directly related work experience(Example: bachelor's degree = 4 years of directly related workexperience). Department may hire employee at one of the following joblevels: Clinical Data Manager, II: Requires a bachelor's (or equivalency) + 4 years or a master's (orequivalency) + 2 years of directly related work experience. Preferences Bachelor's degree in the life sciences, pharmacy, nursing, arelated subject, or equivalency. Prefers two or more years ofrelevant clinical data management experience. Understanding ofbasic regulations involving clinical trials, clinical datamanagement, and clinical data systems. Ability to perform all datamanagement activities associated with a clinical trial with a highdegree of quality. Possess all skills, knowledge and competenciesrequired of the CDM I position. Requisition Number: PRN46075B Full Time or Part Time?: Full Time Work Schedule Summary: Department: 01167 - HCI Clinical Trials Operations Location: Campus Pay Rate Range: 54807.25 Close Date: 11/26/2026 Open Until Filled: #J-18808-Ljbffr Utah

Vacancy posted 13 hours ago
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