Senior Business Systems Analyst

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Job Title:

Senior Business Systems Analyst

Department:

Medicine | Center for Clinical Research Management

The Senior Systems Business Analyst is a fully experienced professional that provides subject matter and technical expertise in clinical research operations and informatics to support, integrate and enhance information technology applications integral to the research mission of The Ohio State University College of Medicine (OSU-COM). Applications include but are not limited to an enterprise-level clinical trials management system (CTMS), enterprise-level regulatory ebinder platform and electronic data capture system, and electronic medical record integrations.

As a part of Clinical Research Operations, the Senior Systems Business Analyst is an experienced technical expert and contributes to the OSU-COM strategic initiatives leading through implementations, upgrades, and support of research informatics applications automating operational, regulatory, financial, and data reporting requirements of the OSU-COM Center for Clinical Research Management. Serves as a point of contact for application vendors for new interoperability, functionality, products, and services to support clinical research. Organizes and leads application stakeholders through complex projects such as assessing and implementing new system initiatives and applies industry knowledge to identify system limitations and provide alternate solutions for workflow.

The Senior Systems Business Analyst participates in and facilitates cross-functional collaborations with multi-disciplinary entities across the OSU-COM, medical center, and the OSU-CCC, including information technology, research billing, and investigational pharmacy. Requirements of the role include advocacy and interaction with and knowledge of principal investigator and staff roles within the OSU-COM Center for Clinical Research Management and key OSU committees, including the Institutional Review Board (IRB), and external organizations such as the National Institutes of Health (NIH).

Oversees gathering of data requirements for research protocol reporting of clinical trials activities, systems notification, and data visualization tools. Works with OSU-COM Center for Clinical Research Management (CCRM) and others to prepare data for significant initiatives and grants.

Creates, implements, and maintains formal training manuals and procedures per industry and federal guidance and collaborates with end-user system training team(s) for implementation and updates. Provides guidance and serves as a subject matter expert resource for colleagues.

Technical skills of this role encompass application troubleshooting of data integrity, functionality, and interfaces within research applications, electronic medical record, financial systems, investigational pharmacy systems, and others as required. Ensures that applications meet appropriate regulatory requirements (e.g., 21CFR 11). The Senior Business Systems Analyst is responsible for controlling access, ensuring the privacy and security of sensitive information within their scope, and following applicable laws and regulations.

Must demonstrate excellent oral and written communication, facilitation skills, consensus building, and the ability to work independently.

Required Education

Bachelor's degree in health science, advanced degree desirable or equivalent combination of education and experience in clinical trials management systems, or clinical research operations (coordinator, regulatory, auditor, etc.)

Experience Required

Four years of relevant clinical background in a clinical research environment with subject matter expertise in clinical research trial office workflows and the ability to navigate complex clinical trial protocols required. Expertise in clinical trials data requirements, regulatory affairs, development of case report forms (CRF), and protocol development a requirement.

Relevant content knowledge of business intelligence tools and report formatting applications (Excel, Tableau, SSRS) preferred. Information technology work experience preferred; extensive work experience interacting within clinical trials/clinical research environment to gather and understand technical and end-user requirements; experience with developing workflow and user documentation preferred; knowledge and experience with a clinical trials management system and electronic health records required.

FUNCTION/SUBFUNCTION: Information Technology/Business Systems

CAREER BAND: Individual Contributor- Specialized

CAREER LEVEL: S3

Additional Information:

This position is a hybrid work position.

Location:

Davis Heart and Lung Research Institute (0113)

Position Type:

Regular

Scheduled Hours:

40

Shift:

First Shift

Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.

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