Clinical Data Managers

Priority Review Date (Note - Posting may close at any time) Job Summary This position is primarily a study lead Clinical Data Manager. It supports multiple clinical study teams by reviewing and/or completing study related clinical data management deliverables. Frequently interacts with study team members to troubleshoot, manage, and develop study specific processes. Actively participates in the development of processes, and documents, that support the clinical data management team. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description. This position is patient-sensitive and must fulfill all associated requirements. We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations. 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 – with impact worldwide. In your cover letter or during your interview process, we invite you to share how your professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include description of your prior experiences related to research, prevention, clinical care, community engagement/outreach, training, administration, or other areas relevant to Huntsman Cancer Institute’s mission and this position. Responsibilities Clinical Data Manager, II Develop data management plans that deliver accurate, timely, and consistent clinical data. Build, review, and maintain clinical databases, data collection tools, and applications. Create, review, and maintain study documentation, such as Case Report Forms (CRFs) and Data Transfer Agreements (DTAs). Contribute to protocol development and review. Compile, analyze, clean, and validate clinical trial data. Identify and resolve discrepancies and issues with clinical data. Develop data management reports and monitor study status to ensure timelines are met. Represent the data management function to key internal and external stakeholders. Work collaboratively with clinical research and operations team to ensure accurate and complete data collection. Requires moderate skill set and proficiency in discipline. Conducts work assignments of increasing complexity, under moderate supervision with some latitude for independent judgment. This is a Developing-Level position in the General Professional track. Essential Functions Participate in the cross-functional project teams as the lead clinical data manager. Provide input in the design of protocols, forms, and data collection 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 established timelines and SOPs. Communicate issues that affect timeline, deliverables, and/or data quality to the study team and functional supervisor. Manage and document the study specific change control process and provide realistic feedback to the study team about impact of proposed changes. Review and provide feedback on other study specific documents. Manage all data management activities of a clinical trial in the maintenance phase of the project. Provide project specific training on electronic data capture ( EDC ) and other data management systems to internal and external personnel. This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. Problem Solving Employees in this position are required to discuss questions and suggestion for improvements with the study team prior to implementing new or modified study specific processes. The Clinical Data Manager II is expected to have a solid understanding of the regulatory framework as it relates to clinical research and data management, and be able to assess current and proposed processes for compliance with regulations and standards. This position is intended to be focused on study level activities with oversight from the manager of clinical data management. Employees are expected to be the independent representative of the clinical data management function on the cross functional study team. Work Environment and Level of Frequency typically required Nearly Continuously: Office environment. Physical Requirements and Level of Frequency that may be required 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 education can be substituted for 1 year of directly related work experience (Example: bachelor’s degree = 4 years of directly related work experience). Department may hire employee at one of the following job levels: Clinical Data Manager, II: Requires a bachelor’s (or equivalency) + 4 years or a master’s (or equivalency) + 2 years of directly related work experience. Preferences Bachelor’s degree in the life sciences, pharmacy, nursing, a related subject, or equivalency. Two or more years of relevant clinical data management experience. Understanding of basic regulations involving clinical trials, clinical data management, and clinical data systems. Ability to perform all data management activities associated with a clinical trial with a high degree of quality. Possess all skills, knowledge and competencies required of the CDM I position. Type Special Instructions Summary Additional Information The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at View phone number on click.appcast.io for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS’ post-retirement rules and restrictions. Please contact Utah Retirement Systems at View phone number on click.appcast.io or View phone number on click.appcast.io or University Human Resource Management at View phone number on click.appcast.io if you have questions regarding the post-retirement rules. This position may require the successful completion of a criminal background check and/or drug screen. The University of Utah values candidates who have experience working in settings with students and possess a strong commitment to improving access to higher education. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities. Consistent with state and federal law, the University of Utah does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy-related conditions, genetic information, or protected veteran’s status. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The requirement not to discriminate in education programs or activities extends to admission and employment. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both. To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Title IX ( OEO ). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at the: University of Utah Non‑Discrimination page . Online reports may be submitted at This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses. They also provide information about safety and security-related services offered by the University of Utah. A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South. As per University of Utah policy 5-108: Transfer of Benefits Eligible Staff Members , a new hire to the University of Utah who is still serving a 12 month probationary period will not be hired into another University of Utah job (a transfer) until the successful completion of the probationary period. Required fields are indicated with an asterisk (*). * What is your highest level of completed education? None High School Diploma or Equivalent Associate Degree Bachelor's Degree Master's Degree Doctorate Degree * How many years of related work experience do you have? Less than 2 years 2 years or more, but less than 4 years 4 years or more, but less than 6 years 6 years or more, but less than 8 years 8 years or more, but less than 10 years 10 years or more, but less than 12 years 12 years or more, but less than 14 years 14 years or more Are you legally authorized to work in the United States? Yes No Will you now or in the future require sponsorship for employment visa status (e.g., H-1B status)? Yes No Do you have any current relatives working in HCI? (Open Ended Question) Required Documents Resume Optional Documents Cover Letter University Human Resource Management 250 East 200 South, Suite 125 Salt Lake City, UT 84111 Contact us: View phone number on click.appcast.io By Email: View email address on click.appcast.io #J-18808-Ljbffr University of Utah