The incumbent leads, plans, coordinates, and documents requirements for small to large scale projects of moderate technical complexity to advance the capabilities of the University of Minnesota (UMN) Clinical Trial Management System (CTMS) and related applications and data reports used to support clinical research, regulatory compliance, and administration. In addition to the CTMS, this role will address the analysis and compliance needs for an Electronic Data Capture (EDC) system and an Electronic Regulatory Binder. The role serves as the technical liaison to coordinate activities between multiple functional areas including product vendors, U of MN Health Sciences Technology (HST), the Office of Information Technology (OIT), OVPR Research Information Systems (ORIS), Cancer Informatics Shared Services (CISS), and other groups as-needed for new technical implementations and maintenance activities. The incumbent will work with a team to maintain compliance for several key clinical research applications. Additional duties include providing service for backup and on escalated customer support tickets, especially those with more technical complexity. The incumbent will work with HST to test and deliver reports and dashboards. This position reports to the CTMS Director.
Technical Business Analysis and Project Coordination – 40% - Document and analyze the scope and business requirements for small to large scale CTMS / clinical application projects of moderate technical complexity. - Coordinate with Health Sciences Technology staff during project execution. - Lead change management activities for the CTMS and associated applications. - Analyze the impact of the changes, coordinate modifications with business owners and key stakeholders. - Conduct stakeholder analysis. - Provide project leadership. - Develop and execute communication plans. - Utilize various modes of communication, such as in-person presentations and working meetings, with technical staff, researchers, service providers, and administrators. - Work with CTMS Director, and internal CTMS colleagues to transfer projects to operations, including the creation of training and support materials. - Develop and execute test plans. - Aim to complete projects within agreed upon scope, time, budget, and quality.
Application Regulatory and Security Compliance – 20% - Conduct the planning and execution of application testing and validation documentation activities to gain and maintain compliance with the FDA’s Code of Federal Regulations (CFR) Title 21 Part 11 at the time of vendor-provided upgrades. - Review and maintain Standard Operating Procedures for UMN security and HIPAA compliance. Work with colleagues to make adjustments to working business processes to maintain compliance. - Actively monitor user and application security-related data. - Keep up to date with IT regulatory and security-related best-practices and regulation changes. - Work with HST Security and OIT Security to strengthen application security. - Report security incidents to the appropriate areas, such as the Privacy Office and University Information Security. Coordinate with these groups for incident resolution.
Maintenance and Operations – 20% - Lead application maintenance and upgrade activities. - Serve as the liaison between CTMS team and technical staff across multiple organizations and functional groups. - Work with vendor technical staff and U of MN server operations team to manage the CTMS environments, databases, and application patches, upgrades, hardware changes, and other technical changes. - Follow best-practice in leading and conducting application functional testing and results documentation. - Coordinate logistics for off-hours work, downtime notifications, and post-upgrade tasks. - Provide off-hours during production maintenance activities. - Document necessary technical information, such as test plans and test results.
CTMS Escalation Point and Support Backup – 10% - Serve as an escalation point for complex and challenging CTMS service tickets. Resolve escalated tickets involving reports, projects, and technical support. - Act as point-person for technical issues. - Provide back-up for support staff. - Provide documentation to internal staff for effective knowledge transfer of the resolution for complex and recurring support issues.
Report Development Support and Other Duties as Assigned - 10% - Coordinate reporting projects with the Health Sciences Technology (HST) Data and Analytics team. - Verify report requirements against business needs prior to HST report development. - Review report output for quality and alignment with the underlying business need. - Other duties will include but will not be limited to: Provide expertise, input, and support for - CTMS change management activities, test updates and system changes, special projects, and attending routine team meetings.
Required: - Bachelor's Degree and two years of professional experience in the area of project management, business analysis, or health care systems administration or four years of work experience in the areas of business or systems process analysis with a non-related degree. - Experience leading projects. - Experience eliciting business requirements. - Working knowledge of regulatory compliance such as FDA CFR Title 21 Part 11 and HIPAA.
Preferred Qualifications: - Experience validating and documenting systems for FDA CFR Title 21 Part 11. - Experience conducting quality assurance on reports and data visualizations. - Data analysis experience. - Experience with application upgrades. - Experience writing and executing application test plans. - Excellent interpersonal skills with the ability to establish and maintain relationships at all organizational levels. - Strong organizational skills, including the ability to handle multiple assignments and tasks while meeting deadlines. - Experience in an academic and/or research environment. - Strong written and verbal communication skills. - Application security monitoring and issue resolution. - Ability to effectively communicate processes, objectives, and details surrounding the use of a complex web-based system to colleagues, customers, and technical staff, both verbally and in written correspondence and documentation. - Experienced working with data base management systems, such as Oracle or other SQL-based database software. - Previous experience developing or supporting patient care, healthcare, or clinic/clinical trials management databases and applications.
Internal Number: 339131
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.