About the position
PS Research Data Coordinator
Job Summary
Clinical Data Managers
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.
Applicants must demonstrate the potential ability to perform the
essential functions of the job as outlined in the position
description.
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.
In your cover letter or during your interview process, we invite
you to share how your 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.
Learn more about the great benefits of working for
University of Utah: benefits.utah.edu
The department may choose to hire at any of the below job
levels and associated pay rates based on their business need and
budget.
Responsibilities
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.
Essential Functions
- Participate in the cross-functional project teams as the lead
clinical data manager.
- Provide input in the design of protocols, forms, and data
collection processes.
- Create and maintain the following study specific documents:
- Data Management Plans
- Edit specifications
- SAE Reconciliation Guidelines
- Other plans and guidelines as required
- Ensure documents are provided according to established
timelines and SOPs.
- Communicate issues that affect timeline, deliverables, and/or
data quality to the study team and functional supervisor.
- Manage and document the study specific change control process
and provide realistic feedback to the study team about impact of
proposed changes.
- Review and provide feedback on other study specific
documents.
- Manage all data management activities of a clinical trial in
the maintenance phase of the project.
- Provide project specific training on electronic data capture
(EDC) and other data management systems to internal and external
personnel.
Disclaimer
This job description has been
designed to indicate the general nature and level of work performed
by employees with 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.
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.
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
EQUIVALENCY STATEMENT: 1 year of higher education
can be substituted for 1 year of directly related work experience
(Example: bachelor's degree = 4 years of directly related work
experience).
Department may hire employee at one of the following job
levels: Clinical Data Manager, II:
Requires a bachelor's (or equivalency) + 4 years or a master's (or
equivalency) + 2 years of directly related work experience.
Preferences
Bachelor's degree in the life sciences, pharmacy, nursing, a
related subject, or equivalency. 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.
Special Instructions
Requisition Number: PRN46471B
Full Time or Part Time? Full Time
Work Schedule Summary:
Department: 01167 - HCI Clinical Trials Operations
Location: Campus
Pay Rate Range: 54807.37
Close Date: 01/06/2027
Open Until Filled:
To apply, visit https://apptrkr.com/9896398"">https://utah.peopleadmin.com/postings/210749
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