Manager, COM Clinical Research Informatics

Manager for the Clinical Research Informatics Team (CRI) within the Center for Clinical Research Management (CCRM) who is responsible for performance management activities, productivity standards, training and guidance, and recruitment/selection for the Clinical Research Informatics team and reports to the Director of Clinical Research Informatics. Develops strategic plans for system upgrades and implementations across the Clinical Research Informatics environment. Serves as the lead technical contributor in planning, development, integration, and support of Clinical Research Enterprise systems, aligned with the strategic objectives of the research organization and the needs of clinical research stakeholders. Collaborates with system vendors, clinical research operations, and informatics engineers to test, validate, and implement new or revised modules within Clinical Research Enterprise systems. Updates validation documentation and Standard Operating Procedures to ensure compliance with Title 21 CFR Part 11 and other applicable regulations. Ensure compliance with federal regulations and institutional policies regarding end-user access to validated clinical research systems. Serves as the primary point of contact for application vendors regarding interoperability, functionality, and new products to support clinical research. Leads stakeholders through complex initiatives such as system assessments and implementations, applying industry knowledge to identify limitations and propose workflow-optimized solutions. Acts as a technical expert and performs advanced business analysis by consulting with research leadership, clinical trial offices, and study teams to gather requirements, assess protocol needs, and translate them into customized data and reporting specifications for Clinical Research Informatics systems.

Minimum Education Requirement

Bachelor’s degree in Computer Science or Health Science or an equivalent combination of education and work experience required.

Required Experience

5 years of relevant experience required.

Preferred Experience

8-12 years of relevant experience preferred.

Desired Education and Experience:
Advanced degree may be desirable. information technology work experience preferred; extensive work experience interacting within a 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 record desired.

Requires successful completion of a background check; selected candidates may be requested to complete a pre-employment physical, including a drug screen.

FUNCTION/SUBFUNCTION: Information Technology/Business Systems

CAREER BAND: People Leader- Managerial

CAREER LEVEL: M2