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A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

Job Summary

The University of Michigan Medical School Clinical Trials Support Office, a unit of the Medical School Office of Research, is seeking an experienced, dynamic professional to serve in a highly visible role as the (change) administrative lead for a new enterprise-wide clinical trials management system, OnCore. This individual will administrate and directly supervise designated OnCore support personnel and coordinate the system support.

In 2014, the University of Michigan Medical School embarked on the strategic priority to transform its clinical trials enterprise by 2018. The Medical School Office of Research has implemented a new organizational structure, common infrastructure, and redesigned business processes necessary to increase the success of our clinical trials portfolio. The organizational structure includes the establishment of a central Clinical Trials Support Office (CTSO) with 7 trans-departmental Clinical Trials Support Units (CTSUs) that are aligned around common areas of research. An enterprise-wide clinical trials management system, OnCore, is being implemented to underpin this organizational structure. OnCore supports the new business processes and standard work and will be the system of record for clinical trial information.

The OnCore administrator (Coordinator) provides direct oversight for the Clinical Trials Management System and is the primary contact for all OnCore-related activities. He/she is responsible for working across multiple levels of the organization, including study teams, operational staff, and senior leadership, to maintain and improve the functionality and use of the system. Key to the success of this position is to assure the business strategy and needs drive the system requirements.  Additionally, this role serves as the “communications hub” to disseminate information to clinical trial team members, Clinical Trials Support Units, central services teams, and senior leadership, as appropriate. This role serves a pivotal function representing the business needs, the people, and the technology. The administrator reports jointly to the Director of Clinical Trials Operations in the Medical School Office of Research and the Senior Director for Research Applications and Advanced Computing in Health Information Technology & Services.

The ideal candidate will have exceptional managerial,communication and interpersonal skills with demonstrated poise and savvy navigating a complex, matrix organization. Through effective collaboration and being a strong team player, the administrator will build trustful, sustained relationships with key constituencies. This person is expected to handle complex situations and multiple responsibilities simultaneously, mixing longer-term project goals with the urgency of immediate demands. They serve as a key change agent for the clinical trials transformation, grasping both the larger overall vision and how OnCore supports that vision.

Responsibilities*

  • Management:
    • Serves as liaison between leadership, OnCore business owner (Clinical Trials Support Office), HITS and end users.
    • Manages all aspects of running OnCore as an enterprise-wide application in a matrix organization. Facilitates synchronization of all teams with operational responsibilities. Has measurable impact on operational effectiveness, attainment of department/unit objectives, service to customers and attainment of research goals.
    • Serves as the primary contact with OnCore users for strategic communications, including, but not limited to, downtime, outages, or new releases. 
    • Provides support during all aspects of whole-scale change management and end user engagement.
    • Works closely with leadership and strategic partners to foster service excellence related to the OnCore program.
    • Directly supervises the staff team including a trainer, report writer, and business analyst(s)
    • Have impact on budgeting, controlling costs, planning, scheduling, and procedural change.
  • Vendor relationship:
    • Coordinates with the vendor on system configuration questions, support issues, and enhancement requests.Develops a working understanding of the unused/new capabilities within the products licensed as well as vendor road map and products not licensed to inform and advise on adoption of future functionality.
    • Serves as a University of Michigan OnCore representative in the OnCore nationwide user community.
    • Recommends product enhancements and requirements to vendor personnel.  
  • OnCore Administration and Coordination: 
    • Works with the team to support development and testing of user roles, design access rights, configuration of Enterprise OnCore for use by clinical research and functional domains. 
    • Oversees administrative aspects of the application such as adding new choices to pick lists, new staff members, and institutions. 
    • Works with the IT team to manage the process for adding and removing user access as well as auditing user access.  
    • Monitors system usage and performance and communicates issues to leadership and IT, as needed.
    • Oversees implementation of the application and database upgrades and coordinates onsite evaluation of new upgrades on the test environment. Provides feedback to vendor regarding the new functionality.  
  • Quality: 
    • Oversees the development and implementation of quality assurance processes for metrics and data elements used enterprise-wide; develops a culture and practice of continuous quality improvement. 
    • Tracks and monitors quality indicators to help inform areas requiring further training or process improvement.  
    • Ensures the integrity and quality of data entry into OnCore.  Identifies, develops, and maintains all applicable policies and SOPs for OnCore use.
  • Team Building: Oversees the direct supervision of selected members of the OnCore Application Support Team, and OnCore assigned business analysts. Maintain robust and consistent processes and artifacts to track user issues, requests, and enhancement ideas. Serves as a senior resource to triage and solve emergent problems, develops user consensus, measures user satisfaction and works to improve user satisfaction. Supervision of the OnCore trainer and the delivery of OnCore training. Supports a very integrated training approach, combining the business processes with the tool being utilized. Serves a key role in continuous quality improvement of the training materials and leads necessary enhancements. Supervises the work of the OnCore report writer and the development of standard and ad hoc reports in support of the various stakeholders.
  • Performs additional functions as needed.

Required Qualifications*

  • Bachelor's degree and 5-7 years (senior classification) or 1-3 years (intermediate classification) work experience in the healthcare or clinical trial industry for the senior classification or work experience in the healthcare.
  • 3-5 years (senior classification) or 1-3 years (intermediate classification) management experience for the senior classification.
  • 3-5 years (senior classification) or 1-3 years (intermediate classification) work experience developing, deploying and supporting enterprise-level information technology software systems.
  • Demonstrated experience building, leading, managing, and mentoring cross-functional teams.
  • Demonstrated knowledge regarding requirements for research involving human subjects and or clinical background and experience.
  • Demonstrated proficiency with OnCore, secondarily of other Clinical Trials Management Systems.
  • Ability to communicate with clinical research teams to explain requirements and vision and resolve questions and QA issues.
  • Demonstrated business acumen.
  • Ability to build strong interpersonal relationships and trust with all constituents.
  • Strong communication skills with ability to effectively translate across the business and IT teams supporting the infrastructure, databases, and interfaces of the application to explain requirements and understand the business implications of technical decisions.
  • Strong written and oral communication skills, attention to detail, customer service orientation and proven ability to perform work accurately and efficiently.
  • Outstanding work ethic and excellent attendance record.
  • Demonstrated ability to work independently and with a team. Excellent organizational and analytic skills, with the proven ability to multitask, trouble shoot and prioritize work.
  • Competency in organizational navigation and ability to deal effectively and persuasively with individuals of varying levels of institutional authority.
  • Ability to use astute judgment, think strategically, analyze logically, and cogently present summaries and recommendations.
  • Demonstrated poise, tact, diplomacy, and unquestionable integrity.
  • Demonstrated proficiency with Microsoft Office, including Outlook, Word and Excel skills.

Work Locations

MBNI 205 Zina Pitcher Place

Underfill Statement

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings.  Background screenings are performed in compliance with the Fair Credit Report Act.

Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally.  Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Application Deadline

Job openings are posted for a minimum of seven calendar days. This job may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.