Job Information

University of Utah Clinical Data Manager III in Salt Lake City, Utah

Open Date 08/12/2021

Requisition Number PRN27289B

Job Title Clinical Data Manager III

Working Title Clinical Data Manager III

Job Grade G

FLSA Code Administrative

Patient Sensitive Job Code? No

Standard Hours per Week 40

Full Time or Part Time? Full Time

Shift Day

Work Schedule Summary

This position may have the option for a hybrid – partial onsite/partial telecommute – work schedule.

VP Area U of U Health - Academics

Department 00952 - Division of Epidemiology

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range 60700 to 101649

Close Date

Open Until Filled Yes

Job Summary

This position is primarily a study / team lead Clinical Data Manager. It supports multiple clinical and informatics focused research study teams by ensuring all study related clinical and health services data management deliverables are completed with a high degree of quality and within timelines. Participates in and/or leads the cross-functional study team as the clinical and health services data management knowledge expert.

Responsibilities

Essential Functions:

  1. Participate or lead the cross-functional project team as the clinical data management knowledge expert.
  2. Contribute to the design of data extraction and study protocols, forms, and data collection processes.
  3. Troubleshoot and implement solutions to issues that arise during the development, management and close out of clinical observational research studies.
  4. Develop timeline for clinical data management deliverables, and ensure they are completed.
  5. Manage and/or complete all study level data management activities with a high degree of quality.
  6. Work with the Manager of CDM to create, modify and implement data management processes.
  7. Use MS SQL server, Git repositories, and statistical platforms (R, SAS , etc.) to extract study information from complex relational electronic health record databases, create analytic files, and generate tabular and visual data summaries.
  8. Use standard methods for extraction of data as well as QC measures to ensure soundness of data.
  9. Conduct statistical analyses up to and including descriptive summaries, bivariate comparisons, and regression modeling in accordance with study protocols and statistical analysis plans.

Problem Solving:

Employees in this position are encouraged to develop and suggest new data management processes and workflow that improve and support the study team. The Clinical Data Manager III is expected to have an in-depth understanding of the regulatory framework as it relates to clinical and health services data management and be able to assess current and proposed processes for compliance with regulations and standards. Successful CDM IIIs have the ability to provide accurate assessments of data management resource requirements for ongoing research studies involving data generated from clinical and electronic health record processes.

Comments:

This position is intended to be focused on study level activities. Employee is expected to be a subject matter expert in clinical and health services data management, actively participate in data management, data abstraction, data analysis, and study team meetings. Will assist in development of data management technical specifications, processes and procedures and is expected to follow all prescribed SOPs and Best Practices.

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. Requires five or more years of relevant clinical data management experience. Possess in-depth understanding of the conduct and regulations involving clinical trials, clinical data management, and clinical data systems, such as Federal ( FDA ) regulations and requirements governing the conduct of clinical trials including, but not limited to, GCP and ICH requirements. Possess in-depth knowledge and understanding of all data management systems and data handling procedures. Demonstrated ability to independently perform all data management activities associated with a clinical trial with minimal oversight and a high degree of quality. Possess all skills, knowledge and competencies required of the CDM I, and CDM II positions.

Preferences

Type Benefited Staff

Special Instructions Summary

Additional Information

The University of Utah values candidates who have experience working in settings with students from diverse backgrounds and possess a strong commitment to improving access to higher education for historically underrepresented students.

Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities and protected veterans are 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:

Director/ Title IX Coordinator

Office of Equal Opportunity and Affirmative Action ( OEO /AA)

135 Park Building

Salt Lake City, UT 84112

801-581-8365

oeo@utah.edu

Online reports may be submitted at oeo.utah.edu

For more information: https://www.utah.edu/nondiscrimination/

To inquire about this posting, email:employment@utah.edu (%20employment@utah.edu) or call 801-581-2300.

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 (801) 581-7447 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 (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 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.