Senior Business Systems Analyst - Comprehensive Cancer Center
New
J
JobgetherClinical Research
Remote within the United StatesFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 4–8 years
- Required Skills
- Data AnalysisMicrosoft Power BITableauMicrosoft ExcelEHR
Requirements
- Bachelor’s degree in health science or a related field; advanced degree preferred.
- 4–8 years of relevant clinical research or clinical operations experience.
- Strong knowledge of clinical trial workflows and ability to navigate complex protocols.
- Demonstrated expertise in clinical trial data requirements, regulatory affairs, case report form development, and protocol development.
- Experience with clinical trial management systems and electronic health records.
- Ability to gather, interpret, and translate technical and end-user requirements.
- Experience developing workflows, standard operating procedures, training materials, or user documentation.
- Strong understanding of applicable clinical research regulations and compliance expectations, including FDA 21 CFR Part 11.
- Experience with business intelligence and reporting tools such as Excel, Tableau, or Power BI preferred.
- IT experience within a clinical research or healthcare environment is an advantage.
- Strong analytical, troubleshooting, facilitation, and consensus-building skills.
- Excellent written and verbal communication skills.
Responsibilities
- Oversee the daily operation and administration of applications supporting clinical research, including troubleshooting, user access management, access audits, and standard operating procedures.
- Coordinate with system vendors, clinical research operations, informatics engineers, IT teams, research billing, and clinical trials offices to test, validate, implement, and support new or enhanced system functionality.
- Contribute to strategic planning for system upgrades, implementations, integrations, and ongoing improvements across the clinical research informatics environment.
- Support systems including clinical trial management platforms, FDA-compliant electronic data capture, eRegulatory solutions, laboratory information systems, clinical trial matching tools, and electronic medical record functionality supporting research.
- Assist with validation documentation and maintain procedures and records in accordance with FDA 21 CFR Part 11 and other applicable regulatory requirements.
- Lead cross-functional discussions and facilitate collaboration among clinical, technical, research, and administrative stakeholders to align solutions with operational needs.
- Develop and maintain training materials, user guides, procedures, and other documentation, while serving as a subject matter expert and resource for colleagues.
- Gather and analyze data requirements for clinical trial reporting, system notifications, dashboards, and data visualization initiatives.
- Partner with data managers and clinical trial subject-matter experts to prepare and support data requirements for major research initiatives and grant activities, including NIH and NCI-related work.
- Advocate for clinical research stakeholders by understanding investigator, principal investigator, coordinator, regulatory, and research staff needs and engaging with relevant institutional committees, including IRB-related groups.
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