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 your experience that directly relates to this position. Being part of something greater, of serving a larger mission of discovery and care- that's the heart of what drives people to work at Michigan. In some way, great or small, every person here helps to advance this world-class institution.…
It's adding a purpose to your profession. Work at Michigan and become a victor for the greater good. The Statistical Analysis of Biomedical and Educational Research (SABER) unit is the data coordinating center for several multi-center clinical trials and observational studies. We are a research center located within the Biostatistics Department at the School of Public Health (SPH) on Michigan's central campus. We work with clinical centers to move the project forward according to Good Clinical Practice (GCP) guidelines.We are looking for an experienced and dynamic staff member to contribute positively to our community. You will help to lead the project management team in addition to managing your own clinical trials. You will report to the SABER Assistant Director of Project Management and Quality. You may be asked to travel (no more than 5%) within the United States and possibly internationally to participating clinical centers and investigator meetings. SABER prides itself on fostering a collegial, open, and family friendly work environment, and our team is fully remote. This will be a 5-year term-limited position with possibility of extension contingent on funding availability. For more information on SABER, please visit: https://sph.umich.edu/saber/index.html . For more information on the Biostatistics Department, please visit: https://sph.umich.edu/biostat/ Portfolio leadership and delivery oversight Maintain accountability for portfolio-level delivery (timelines, quality, risk, and performance across studies) Collaborate with the Assistant Director to plan and optimize resource allocation and workload Ensure all studies are conducted in compliance with regulatory requirements, adhere to internal quality standards, and meet organizational expectations for timelines, quality, and performance Provide backup support to project managers to ensure continuity of study operations as needed Study execution and hands-on project management Serve as lead project manager on select trials with full responsibility for planning, execution, and delivery Support the development and execution of clinical trials, observational studies, and registries from startup through closeout People management and team development Directly manage project managers, including performance management, coaching, and career development Provide ongoing mentorship, training, and feedback to strengthen team capability Foster a collaborative, high-performing team culture Cross-functional leadership and process improvement Lead coordination across project management, clinical monitoring, quality, data management, biostatistics, and software development Design, implement, and standardize workflows, SOPs, and best practices Drive continuous process improvement and scalable operational efficiencies Strategic contributions and external engagement Contribute to grant proposals, progress reports, and manuscripts Present project management, clinical operations, and quality initiatives at professional meetings and external forums Master's degree in Public Health, Clinical Research, or a related discipline Minimum 7 years of progressive multi-center clinical trials experience and/or observational studies, including direct project management responsibility across multiple multi-center studies Minimum 5 years of formal people management experience of 3 or more direct reports, with oversight of project managers or equivalent roles Minimum of 5 years of experience working with project management applications/tools, managing projects, initiatives, staff, and documentation (Examples of tools - Microsoft Project, Jira, Asana, ClickUp, Monday, etc.) Demonstrated ability to lead both strategically and operationally Proven experience managing complex, multi-center clinical trials in an academic, CRO, or industry setting Strong track record of team leadership, cross-functional integration, and driving organizational or operational change Knowledge of ICH-GCP, FDA regulations, and applicable guidelines governing human participant research, with demonstrated application in practice Demonstrated experience designing, implementing, and optimizing workflows and process improvements at the team or program level Experience interacting with or supporting Data Safety Monitoring Boards (DSMBs) Experience in quality management, audit readiness, or regulatory inspection support Demonstrated experience designing, implementing, and optimizing workflows and process improvements at the team or program level This position may be underfilled at a lower classification depending on the qualifications of the selected candidate. Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled any time after the minimum posting period has ended. The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.
