University of Utah
Overview
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Data Manager
role at
University of Utah . This position supports the Research Compliance Office in managing data for oncology clinical trials, ensuring data is accurate, complete, and entered in a timely manner to support valid, high-quality publications. The role collaborates with the Principal Investigator (PI), Biostatistician, Protocol Writer, and other members of the clinical research team. Responsibilities include developing, validating, amending, and analyzing electronic case report forms (eCRF) in accordance with the IIT protocol and data management plan, and reporting study progress to the Data Safety Monitoring Committee (DSMC). The primary focus is maintaining accurate primary and secondary data histories. Responsibilities
Develop the data management plan and electronic case report forms (eCRF) in accordance with the IIT protocol and the associated statistical analysis plan, with direction from the PI, Biostatistician, Research Compliance Officer, and the clinical research team. Perform routine data validation checks of the eCRFs during routine monitoring visits for IITs. Track OnCore calendar visit completion dates to verify data accuracy and completeness. Determine IIT data currency and ensure it is >80%. Collaborate with Research Compliance Officers to resolve data inconsistencies and report to the DSMC and regulatory agencies as needed. Generate electronic queries to resolve data inconsistencies. Prepare for routine monitoring visits and audits by resolving eCRF queries. Review responses to queries to ensure appropriate resolution and address discrepancies. Provide metrics and data analysis reports to the DSMC on a monthly basis. Review reports prepared for presentation to the DSMC to ensure data consistency and accuracy. Work with the PI and statistician to create a data management plan and set data-lock dates per the protocol. Export, review, and validate data exports for consistency with the protocol requirements. Review data for formatting and missing data points; organize data per PI and statistician recommendations. Coordinate as a point of contact for data management questions on multiple IIT projects. Track IIT protocol amendments and update eCRFs to maintain protocol compliance; amend eCRFs as needed for quality control and system upgrades. Perform quality assurance reviews for data on Industry Sponsored trials and National Cancer Trials Network studies as needed. Assist in developing, implementing, and optimizing data collection systems and other strategies to enhance data quality and completeness. Assist in creating clinical research reporting documents (manuscripts, posters, or presentations) to present data clearly and objectively. Ensure compliance with results reporting for clinicaltrials.gov. Recommend enhancements to SOPs and policies for compliance; develop departmental SOPs. Minimum Qualifications
Bachelor's degree in a health science or related field or equivalent (one year of education can substitute for two years of related work experience); and four years of clinical research experience including regulatory compliance monitoring/auditing, IRB submissions, and human subjects research. Working knowledge of FDA, ICH, and other regulatory requirements; understanding of medical terminology and technical writing. Excellent interpersonal communication (oral and written) and leadership skills. Proficiency in Microsoft Office and ability to learn new software programs. This position is patient-sensitive and requires immunization per CDC standards and hospital policy unless exemptions apply for medical or religious reasons. Preferences
Credentialing as CCAR/CCRC/CCRP or equivalent; prior experience as an industry CRA or Monitor is preferred. Minimum 3 years of relevant data management experience. Oncology clinical trial experience preferred. Knowledge of FDA, OHRP, ICH GCP, and related guidelines; ability to manage multiple projects and timelines. Strong attention to detail, prioritization, and ability to work independently and meet deadlines. Excellent communication skills. Location: Campus, Salt Lake City, UT. Full-time position with a hybrid schedule as applicable.
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Join to apply for the
Data Manager
role at
University of Utah . This position supports the Research Compliance Office in managing data for oncology clinical trials, ensuring data is accurate, complete, and entered in a timely manner to support valid, high-quality publications. The role collaborates with the Principal Investigator (PI), Biostatistician, Protocol Writer, and other members of the clinical research team. Responsibilities include developing, validating, amending, and analyzing electronic case report forms (eCRF) in accordance with the IIT protocol and data management plan, and reporting study progress to the Data Safety Monitoring Committee (DSMC). The primary focus is maintaining accurate primary and secondary data histories. Responsibilities
Develop the data management plan and electronic case report forms (eCRF) in accordance with the IIT protocol and the associated statistical analysis plan, with direction from the PI, Biostatistician, Research Compliance Officer, and the clinical research team. Perform routine data validation checks of the eCRFs during routine monitoring visits for IITs. Track OnCore calendar visit completion dates to verify data accuracy and completeness. Determine IIT data currency and ensure it is >80%. Collaborate with Research Compliance Officers to resolve data inconsistencies and report to the DSMC and regulatory agencies as needed. Generate electronic queries to resolve data inconsistencies. Prepare for routine monitoring visits and audits by resolving eCRF queries. Review responses to queries to ensure appropriate resolution and address discrepancies. Provide metrics and data analysis reports to the DSMC on a monthly basis. Review reports prepared for presentation to the DSMC to ensure data consistency and accuracy. Work with the PI and statistician to create a data management plan and set data-lock dates per the protocol. Export, review, and validate data exports for consistency with the protocol requirements. Review data for formatting and missing data points; organize data per PI and statistician recommendations. Coordinate as a point of contact for data management questions on multiple IIT projects. Track IIT protocol amendments and update eCRFs to maintain protocol compliance; amend eCRFs as needed for quality control and system upgrades. Perform quality assurance reviews for data on Industry Sponsored trials and National Cancer Trials Network studies as needed. Assist in developing, implementing, and optimizing data collection systems and other strategies to enhance data quality and completeness. Assist in creating clinical research reporting documents (manuscripts, posters, or presentations) to present data clearly and objectively. Ensure compliance with results reporting for clinicaltrials.gov. Recommend enhancements to SOPs and policies for compliance; develop departmental SOPs. Minimum Qualifications
Bachelor's degree in a health science or related field or equivalent (one year of education can substitute for two years of related work experience); and four years of clinical research experience including regulatory compliance monitoring/auditing, IRB submissions, and human subjects research. Working knowledge of FDA, ICH, and other regulatory requirements; understanding of medical terminology and technical writing. Excellent interpersonal communication (oral and written) and leadership skills. Proficiency in Microsoft Office and ability to learn new software programs. This position is patient-sensitive and requires immunization per CDC standards and hospital policy unless exemptions apply for medical or religious reasons. Preferences
Credentialing as CCAR/CCRC/CCRP or equivalent; prior experience as an industry CRA or Monitor is preferred. Minimum 3 years of relevant data management experience. Oncology clinical trial experience preferred. Knowledge of FDA, OHRP, ICH GCP, and related guidelines; ability to manage multiple projects and timelines. Strong attention to detail, prioritization, and ability to work independently and meet deadlines. Excellent communication skills. Location: Campus, Salt Lake City, UT. Full-time position with a hybrid schedule as applicable.
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