PS Clinical Data Manager II

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Open Date 05/16/2024 Requisition Number PRN38572B Job Title PS Clinical Data Manager II Working Title Research Data Coordinator Job Grade E FLSA Code Administrative Patient Sensitive Job Code? Yes Standard Hours per Week 40 Full Time or Part Time? Full Time Shift Day Work Schedule Summary VP Area President Department HCI Clinical Trials Operations Location Campus City Salt Lake City, UT Type of Recruitment External Posting Pay Rate Range 39300 to 72700 Close Date Open Until Filled Yes 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.

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. Partnerships with individuals, communities, and many other entities are crucial to our work. Huntsman Cancer Institute values cancer-related health equity, and inclusion as integral to our guiding principle to serve our patients and their communities, and our commitment to foster a culture of belonging for all within our organization.

In your cover letter or during your interview process, we invite you to share how your personal and 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.

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Responsibilities

1. Participate in the cross-functional project teams as the lead clinical data manager.
2. Provide input in the design of protocols, forms, and data collection processes.
3. Create and maintain the following study specific documents:
4. Data Management Plans
5. Edit specifications
6. SAE Reconciliation Guidelines
7. Other plans and guidelines as required
8. Ensure documents are provided according to established timelines and SOPs.
9. Communicate issues that affect timeline, deliverables, and/or data quality to the study team and functional supervisor.
10. Manage and document the study specific change control process and provide realistic feedback to the study team about impact of proposed changes.
11. Review and provide feedback on other study specific documents.
12. Manage all data management activities of a clinical trial in the maintenance phase of the project.
13. 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.

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

Bachelor's degree in the life sciences, pharmacy, nursing, a related subject, or equivalency (one year of education can be substituted for two years of related work experience). Requires 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.

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.

Preferences Type Benefited Staff 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 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 or or University Human Resource Management at 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 patients from all backgrounds and possess a strong commitment to improving access to higher education and quality healthcare for historically underrepresented students and patients.

All qualified individuals are strongly encouraged to apply. 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.

The University of Utah is an Affirmative Action/Equal Opportunity employer and 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 Affirmative Action (OEO/AA). More information, including the Director/Title IX Coordinator's office address, electronic mail address, and telephone number can be located at:

Online reports may be submitted at

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Posting Specific Questions

Required fields are indicated with an asterisk (*).

• Do you have a Bachelor's degree in a related area?
• Yes
  • No
• Do you have any current relatives working in HCI?

(Open Ended Question)

Applicant Documents

Required Documents

• Resume

Optional Documents

• Cover Letter
• Appropriate discharge document (such as a DD-214 - Member Copy 4) - Veteran Only - Call
• Addendum to the University of Utah - Veteran Only - Call after submission