Address
Form of workAnnouncement
Details
Open Date
06/21/2023
Requisition Number
PRN35409B
Job Title
PS Clinical Data Manager II
Working Title
PS 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
VP Area
President
Department
01167 - HCI Clinical Trials Operations
Location
Campus
City
Salt Lake City, UT
Type of Recruitment
External Posting
Pay Rate Range
39300 to 53989
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 (HCI) is an Equal Opportunity Employer committed to hiring individuals whose merit and experience promote a diverse, inclusive, anti-racist workforce and culture.
Each employee has a unique background and life experience. We believe that maximizing diversity fuels the success of our organization. In your cover letter or during your interview, we invite you to share how your background, beliefs, and experience will prepare you to be effective in working in an environment that values diversity and is committed to equity, diversity, and inclusion.
Learn more about HCI's commitments at huntsmancancer.org/edi and/or contact HCI's Office of Equity, Diversity, and Inclusion.
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:
• Data Management Plans
• Edit specifications
• SAE Reconciliation Guidelines
• 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.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description
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.
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. 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 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)
383 University Street, Level 1 OEO Suite
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 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.
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.
Details
Open Date
06/21/2023
Requisition Number
PRN35409B
Job Title
PS Clinical Data Manager II
Working Title
PS 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
VP Area
President
Department
01167 - HCI Clinical Trials Operations
Location
Campus
City
Salt Lake City, UT
Type of Recruitment
External Posting
Pay Rate Range
39300 to 53989
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 (HCI) is an Equal Opportunity Employer committed to hiring individuals whose merit and experience promote a diverse, inclusive, anti-racist workforce and culture.
Each employee has a unique background and life experience. We believe that maximizing diversity fuels the success of our organization. In your cover letter or during your interview, we invite you to share how your background, beliefs, and experience will prepare you to be effective in working in an environment that values diversity and is committed to equity, diversity, and inclusion.
Learn more about HCI's commitments at huntsmancancer.org/edi and/or contact HCI's Office of Equity, Diversity, and Inclusion.
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:
• Data Management Plans
• Edit specifications
• SAE Reconciliation Guidelines
• 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.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description
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.
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. 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 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)
383 University Street, Level 1 OEO Suite
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 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.
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.
