Job Details

Data Manager

Position Number: 6605350
Location: Salt Lake City, UT
Position Type: Laboratory and Research

Data Manager

Job Summary

The Research Compliance Office Data Manager will ensure data for oncology clinical trials is accurate, complete and entered in a timely manner, so that data generated for publication is valid, high-quality, reliable, and statistically sound. This position will work closely with numerous members of the clinical research team including the Principal Investigator (PI), Biostatistician, and Protocol Writer. This position will be responsible for developing, validating, amending, and analyzing electronic case report forms (eCRF) in accordance with the investigator-initiated trial (IIT) protocol and data management plan. This position will also report on the study progress as it relates to IIT data to the Data Safety Monitoring Committee. The primary focus of this position will be to ensure accurate case histories are maintained with respect to the primary and secondary data.

This position has the capability of working a hybrid schedule with partially remote options.

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

Develops the data management plan and electronic case report forms (eCRF) in accordance with the investigator-initiated trial (IIT) protocol and the associated statistical analysis plan with direction from the Principal Investigator (PI), Biostatistician, Research Compliance Officer and the clinical research team.
Performs routine data validation checks of the eCRFs at the time of routine monitoring visits for all IITs.
Tracks OnCore calendar visit completion dates to verify the accuracy and completeness of the data.
Responsible for determining IIT data currency and ensuring it is >80%.
Works closely with the Research Compliance Officers to resolve problematic data inconsistencies to ensure appropriate reporting to the Data Safety Monitoring Committee (DSMC) and regulatory agencies as necessary.
Generates electronic queries, when appropriate, to resolve inconsistencies in data.
Prepares for routine monitoring visits and audits by ensuring eCRF query resolution.
Review responses to queries to ensure appropriate resolution and resolve any discrepancies
Provide metrics and data analysis reports to the DSMC on a monthly basis.
Review reports prepared by the Research Compliance Officer for presentation to the DSMC to ensure consistency and accuracy in the data.
Work with the PI and statistician to create a data management plan and set data-lock dates in accordance with the protocol.
Export, review, and validate data exports for consistency to facilitate consistent data and ensure data captured follows the requirements outlined in the protocol.
Review data for formatting and any missing data points. Organize the data based on the recommendations from the PI and statistician.
Coordinate and act as a point of contact for data management questions on multiple IIT projects.
Tracks IIT protocol amendments to ensure eCFRs are updated as appropriate to facilitate protocol compliance. Amends eCRFs as necessary for quality control purposes and business system upgrades.
Perform quality assurance reviews for data on Industry Sponsored trials and National Cancer Trials Network studies as needed.
Assist in the development, implementation and optimization of data collection systems and other strategies that enhance data quality and completeness.
As needed, manage the creation of clinical research reporting documents such as manuscripts, posters or oral presentations to present data objectively in a clear, concise format.
Responsible for ensuring compliance with results reporting for clinicaltrials.gov
Recommends enhancements to standard operating policies and procedures for compliance review. Develop departmental SOPs.

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.

Minimum Qualifications
Bachelor's degree in a health science or related field or equivalency (one year of education can be substituted for two years of related work experience); and four years of clinical research experience that includes regulatory compliance monitoring/auditing, IRB application submission, and experience in human subjects research. Must have a working knowledge of FDA, ICH, and other regulatory compliance; an understanding of medical terminology and technical writing experience. Excellent interpersonal communication (including oral and written) and leadership skills also required. Must be proficient in Microsoft Office and possess the ability to learn new software programs.

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 include credentialing as a Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), and/or Certified Clinical Research Professional (CCRP). Prior experience as an industry CRA or Monitor is also preferred.

Hiring department may require certification by an appropriate certifying body within two years of hire.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Preferences

Minimum 3 years of relevant data management experience.
Certified Clinical Research Professional (CCRP, CCRC, or CCRA).
Oncology clinical trial experience preferred.
Working knowledge of Food and Drug Administration (FDA) requirements, Office of Human Research Protection (OHRP), International Conference of Humanization (ICH) Good Clinical Practice (GCP), as well as state and federal guidelines.
Knowledge of clinical development process sufficient to effectively direct and manage multiple projects and timelines.
Strong attention to detail, establishing priorities, and adhering to deadlines.
Able to work independently, and complete tasks to meet deadlines.
Excellent communication skills.

Special Instructions

Requisition Number: PRN43208B
Full Time or Part Time? Full Time
Work Schedule Summary:
Department: 01345 - HCI Clinical Resrch Compliance
Location: Campus
Pay Rate Range: 47600 to 84000
Close Date: 12/31/2025
Open Until Filled:

To apply, visit https://utah.peopleadmin.com/postings/189498