Senior Business Systems Analyst - Comprehensive Cancer Center

Accountabilities:

• 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.

Requirements:

• Bachelor’s degree in health science or a related field, with an advanced degree preferred; equivalent education and experience in clinical research operations or clinical trial systems may also be considered.
• 4–8 years of relevant clinical research or clinical operations experience, with strong knowledge of clinical trial workflows and the 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 is required, along with the ability to gather, interpret, and translate technical and end-user requirements.
• Knowledge of clinical research operations and experience working with clinical trial coordinators, regulatory professionals, auditors, investigators, or related stakeholders.
• Experience developing workflows, standard operating procedures, training materials, or user documentation is highly valuable.
• Familiarity with business intelligence and reporting tools such as Excel, Tableau, or Power BI is preferred.
• IT experience within a clinical research or healthcare environment is an advantage, particularly experience supporting enterprise applications and technology implementations.
• Strong analytical, troubleshooting, facilitation, and consensus-building skills, with the ability to work independently and manage competing priorities.
• Excellent written and verbal communication skills, with the ability to explain complex technical and clinical concepts to multidisciplinary audiences.
• Ability to collaborate effectively with vendors, researchers, clinicians, IT professionals, data managers, and administrative stakeholders.
• Strong understanding of applicable clinical research regulations and compliance expectations, including FDA 21 CFR Part 11.
• Final candidates must successfully complete a background check; a drug screen or physical examination may be required as part of the post-offer process.

Benefits:

• Full-time, regular position with a 40-hour workweek and first-shift schedule.
• Remote work within the United States.
• Medical, dental, and vision coverage, with the employer covering a significant portion of the cost.
• Paid time off, including sick leave, vacation time, and 11 paid holidays.
• State retirement plan or alternative retirement plan with generous employer contributions.
• Opportunities for professional development and career growth within a large academic healthcare and research environment.
• Opportunity to contribute to clinical research, healthcare innovation, and technology initiatives with meaningful institutional impact.