[Hiring] Senior Business Systems Analyst @The Ohio State University

Role Description

Responsible for daily oversight and operation of CRI-supported applications. Manages troubleshooting, administers and controls user access, conducts access audits, and documents standard operating procedures for application-related processes.

• Coordinates with system vendors, clinical research operations, and informatics engineers to test, validate, and implement new or revised modules within Clinical Research Enterprise systems.
• Assists in updating validation documentation and Standard Operating Procedures to ensure compliance with FDA 21 CFR Part 11 and other applicable regulations.
• Leads and facilitates cross-functional collaboration with multi-disciplinary teams across the medical center's clinical research enterprise, including information technology, research billing, and clinical trials offices.
• Participates in developing strategic plans for system upgrades and implementations across the Clinical Research Informatics environment.
• Acts as a technical contributor in planning, development, integration, and support of OSUMC Clinical Research Enterprise systems.
• Creates, implements, and maintains formal training manuals and procedures per industry and federal guidance.
• Provides guidance and serves as a subject matter expert resource for colleagues.
• Oversees the collection of data requirements for research protocol reporting of clinical trial activities, system notifications, and related data visualization tools.
• Collaborates with data managers and clinical trials subject-matter experts to prepare data for major initiatives and grants, including NIH and NCI.
• Must demonstrate excellent oral and written communication, facilitation skills, consensus-building abilities, and the capacity to work independently.

Qualifications

• Bachelor’s degree in health science; advanced degree preferred or equivalent combination of education and experience in clinical trials management systems or clinical research operations.
• Four to eight years of relevant clinical experience in a clinical research setting with subject matter expertise in clinical trial workflows.
• Ability to navigate complex protocols.
• Expertise in clinical trial data requirements, regulatory affairs, case report form (CRF) development, and protocol development.
• Knowledge of business intelligence tools and report formatting applications (Excel, Tableau, Power BI) is preferred.
• IT work experience is also preferred; extensive experience in clinical trials or research environments is valuable.
• Experience developing workflows and user documentation is a plus.
• Knowledge and experience with clinical trial management systems and electronic health records are required.

Requirements

• Advocacy, interactions with, and knowledge of principal investigator and staff roles within the medical center's clinical research enterprise.
• Engagement with key OSU committees related to the Institutional Review Board (IRB).

Benefits

• Remote Location
• Regular Position Type
• Scheduled Hours: 40
• Shift: First Shift