PS Clinical Data Manager II
University of Utah
Salt Lake City, UT
Full-time
Information Services / Technology (IT)
Posted on April 16, 2024
Announcement
Details
Open Date
04/12/2024
Requisition Number
PRN38241B
Job Title
PS Clinical Data Manager II
Working Title
Clinical Data Manager II
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
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
39300 to 68349
Close Date
Open Until Filled
Yes
Job Summary
Work with a talented team of developers, researchers, and clinicians in the University of Utah Division of Epidemiology to conduct large-scale research projects in the domain of infectious diseases. The successful candidate will work collaboratively to develop analysis plans and technical specifications, maintain study documentation, create study cohorts and analytic files from relational databases, and conduct basic and advanced statistical analyses within the US Department of Veterans Affairs (VA) Corporate Data Warehouse ( CDW) and the University of Utah Center for High Performance Computing ( CHPC) environments.
Opportunity for advancement depending upon experience and performance.
Responsibilities
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 vaccination requirements, or be approved for an exemption, prior to the first day of work. 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.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
Essential Functions
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:
a. Data Management Plans
b. Edit specifications.
c. SAE Reconciliation Guidelines
d. Other plans and guidelines as required.
4. Ensure documents are provided according to established timelines and SOPs.
5. Communicate issues that affect timeline, deliverables, and/or data quality to the study team and functional supervisor.
6. Manage and document the study specific change control process and provide realistic feedback to the study team about impact of proposed changes.
7. Review and provide feedback on other study specific documents.
8. Manage all data management activities of a clinical trial in the maintenance phase of the project.
9. Provide project specific training on electronic data capture ( EDC) and other data management systems to internal and external personnel.
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.
Comments
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.
Disclaimer
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.
Work Location and Schedule
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.
Work Environment and Level of Frequency that may be 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
- Previous experience VA CDW, University Electronic Data Warehouse ( EDW), or other large electronic health record or administrative healthcare data sets strongly preferred.
- Proficient in data analysis and management familiar with Microsoft Business Intelligence stack.
- Experience with TSQL, SSIS, SSRS, SSAS and Power BI strongly preferred.
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 (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 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: https://www.utah.edu/nondiscrimination/
Online reports may be submitted at oeo.utah.edu
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
04/12/2024
Requisition Number
PRN38241B
Job Title
PS Clinical Data Manager II
Working Title
Clinical Data Manager II
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
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
39300 to 68349
Close Date
Open Until Filled
Yes
Job Summary
Work with a talented team of developers, researchers, and clinicians in the University of Utah Division of Epidemiology to conduct large-scale research projects in the domain of infectious diseases. The successful candidate will work collaboratively to develop analysis plans and technical specifications, maintain study documentation, create study cohorts and analytic files from relational databases, and conduct basic and advanced statistical analyses within the US Department of Veterans Affairs (VA) Corporate Data Warehouse ( CDW) and the University of Utah Center for High Performance Computing ( CHPC) environments.
Opportunity for advancement depending upon experience and performance.
Responsibilities
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 vaccination requirements, or be approved for an exemption, prior to the first day of work. 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.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
Essential Functions
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:
a. Data Management Plans
b. Edit specifications.
c. SAE Reconciliation Guidelines
d. Other plans and guidelines as required.
4. Ensure documents are provided according to established timelines and SOPs.
5. Communicate issues that affect timeline, deliverables, and/or data quality to the study team and functional supervisor.
6. Manage and document the study specific change control process and provide realistic feedback to the study team about impact of proposed changes.
7. Review and provide feedback on other study specific documents.
8. Manage all data management activities of a clinical trial in the maintenance phase of the project.
9. Provide project specific training on electronic data capture ( EDC) and other data management systems to internal and external personnel.
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.
Comments
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.
Disclaimer
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.
Work Location and Schedule
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.
Work Environment and Level of Frequency that may be 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
- Previous experience VA CDW, University Electronic Data Warehouse ( EDW), or other large electronic health record or administrative healthcare data sets strongly preferred.
- Proficient in data analysis and management familiar with Microsoft Business Intelligence stack.
- Experience with TSQL, SSIS, SSRS, SSAS and Power BI strongly preferred.
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 (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 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: https://www.utah.edu/nondiscrimination/
Online reports may be submitted at oeo.utah.edu
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 related Bachelor's degree or equivalency? (2 years related work experience may be substituted for 1 year of education)
- 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
