PS Research Data Coordinator

Utah; Salt Lake City (UT); On-site; USD 90,000 - 130,000; Full time

Job summary

Huntsman Cancer Institute is seeking a Study Lead Clinical Data Manager to support multiple clinical study teams by reviewing and completing study-related data management deliverables. You will troubleshoot, manage, and develop study-specific processes, ensuring adherence to timelines and SOPs within the clinical data management function.

The role emphasizes development of processes, regulatory compliance, and independent representation on cross-functional study teams to advance cancer

Qualifications

• Requires a bachelor’s degree (or equivalency) + 4 years or a master’s (or equivalency) + 2 years of directly related work experience.
• Solid understanding of regulatory framework as it relates to clinical research and data management.
• Experience supporting cross-functional study teams and developing study-specific processes.

Responsibilities

• Lead clinical data management as part of cross-functional project teams.
• Input in protocol, form, and data collection design.
• Create and maintain study documents: Data Management Plans, edit specifications, SAE reconciliation guidelines, and other plans.

Skills

Cross-functional collaboration

Clinical Data Management

Timeline management

Education

Bachelor's degree or equivalent in related field

Tools

EDC systems

Job description

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 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.

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

1. Ensure documents are provided according to established timelines and SOPs.
2. Communicate issues that affect timeline, deliverables, and/or data quality to the study team and functional supervisor.
3. Manage and document the study specific change control process and provide realistic feedback to the study team about impact of proposed changes.
4. Review and provide feedback on other study specific documents.
5. Manage all data management activities of a clinical trial in the maintenance phase of the project.
6. Provide project specific training on electronic data capture ( EDC ) and other data management systems to internal and external personnel.

Employees in this position are required to discuss questions and suggestions 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 assess current and proposed processes for compliance with regulations and standards. This position is intended to focus 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 Frequency

Nearly Continuously: Office environment.

Physical Requirements

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.

Screening Requirements

This position may require the successful completion of a criminal background check and/or drug screen.

Equal Employment Opportunity

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

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.

Consistent with state and federal law, the University of Utah 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 Title IX (OEO). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at the University of Utah Non‑Discrimination page. Online reports may be submitted at https://oeo.utah.edu.