Clinical Data Manager III
University of Utah
Salt Lake City, UT
Full-time
Information Services / Technology (IT)
Posted on April 10, 2024
Announcement
Details
Open Date
02/07/2024
Requisition Number
PRN37657B
Job Title
Clinical Data Manager III
Working Title
Data Manager
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
Employees must reside in the state of Utah but might have the opportunity to work a hybrid (in-office and remote) work schedule. Possible consideration of a request for a fully remote work schedule, subject to approval and change.
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
60,700 to 109,649
Close Date
Open Until Filled
Yes
Job Summary
This position is primarily a study / team lead Clinical Data Manager. It supports multiple clinical study teams by ensuring all study related clinical 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 data management knowledge expert.
This position is contingent based upon continued funding and may be temporary.
Responsibilities
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 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
To inquire about this posting, email: employment@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.
The University of Utah values candidates who have experience working in settings with students from all backgrounds and possess a strong commitment to improving access to higher education for historically underrepresented students.
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:
Online reports may be submitted atoeo@utah.edu
For more information:https://www.utah.edu/nondiscrimination/
Online reports may be submitted at oeo.utah.edu
For more information: https://www.utah.edu/nondiscrimination/
https://safety.utah.edu/safetyreport 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.
Posting Specific Questions
Required fields are indicated with an asterisk (*).
Required Documents
Details
Open Date
02/07/2024
Requisition Number
PRN37657B
Job Title
Clinical Data Manager III
Working Title
Data Manager
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
Employees must reside in the state of Utah but might have the opportunity to work a hybrid (in-office and remote) work schedule. Possible consideration of a request for a fully remote work schedule, subject to approval and change.
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
60,700 to 109,649
Close Date
Open Until Filled
Yes
Job Summary
This position is primarily a study / team lead Clinical Data Manager. It supports multiple clinical study teams by ensuring all study related clinical 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 data management knowledge expert.
This position is contingent based upon continued funding and may be temporary.
Responsibilities
- Participate or lead the cross-functional project team as the clinical data management knowledge expert.
- Contribute to the design of protocols, forms, and data collection processes.
- Troubleshoot and implement solutions to issues that arise during the development, management and close out of clinical studies.
- Develop timeline for clinical data management deliverables, and ensure they are completed.
- Manage and/or complete all study level data management activities with a high degree of quality.
- Work with the Manager of CDM to create, modify and implement data management processes.
- Provide in-house expertise on data management related technical subject matter. (i.e. CDISC, 21 CFR Part 11, Systems validation, etc.)
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 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
To inquire about this posting, email: employment@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.
The University of Utah values candidates who have experience working in settings with students from all backgrounds and possess a strong commitment to improving access to higher education for historically underrepresented students.
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:
Online reports may be submitted atoeo@utah.edu
For more information:https://www.utah.edu/nondiscrimination/
Online reports may be submitted at oeo.utah.edu
For more information: https://www.utah.edu/nondiscrimination/
https://safety.utah.edu/safetyreport 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.
Posting Specific Questions
Required fields are indicated with an asterisk (*).
- * Do you have a Bachelor's degree in a related area?
- Yes
- No
- How many years of data management experience do you have?
- Less than 1 year
- 1 year or more, but 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
Required Documents
- Resume
- Cover Letter
- Appropriate discharge document (such as a DD-214 – Member Copy 4) – Veteran Only – Call 801.581.2169
- Addendum to the University of Utah - Veteran Only - Call 801.581.2169 after submission
- List of References
