How to Apply

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.

Summary

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. SABER program managers provide project oversight and coordinate the project team efforts together with study principal investigators or clinical coordinating center leadership. We work with clinical sites to move the project forward according to good clinical practice (GCP) guidelines. We are looking for an experienced and dynamic staff member with a commitment to contributing to a diverse, equitable, and inclusive environment for all members of our community.

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/index.html

Responsibilities*

Program Management Functions:

• Support the concept development, design, and conduct of one or more large and complex research projects according to the project plan; review progress in accordance with project timeline and evaluate results.
• Leading functional area initiatives such as creating training materials, SOPs, and work instructions in collaboration with other team members.
• Formulate research methods and suggest options for improving quality; identify potential problems, recommend, and implement solutions.
• Work collaboratively with functional groups to develop workflows and processes to streamline cross functional study activities.
• Provide mentorship to SABER project managers and clinical research associates in accordance with SABER's policies and procedures.
• Assist the portfolio manager to meet the organization's expectations for productivity, quality, and goal accomplishment.
• Support grant proposal writing in collaboration with the other team members.

Project Management Functions:

• Coordinate and attend various study related meetings and web conferences, including preparing agendas and taking minutes.
• Prepare clinical sites for study startup by reviewing and tracking regulatory documents, ordering startup supplies) and conducting site initiation visits.
• Assist with designing electronic case report forms, database validation and error variables for data entry.
• Maintain study manual of operations, trial master files, and standard data collection procedures for participating clinical sites.
• Appropriately communicate information through team meetings, one-on-one meetings, and appropriate email, phone, and face-to-face interpersonal communication, as well as implement best practices for effective communication by the PM/CM group.
• Help with IRB submissions for DCC activities and annual scheduled renewals.
• Provide oversight and assistance to clinical monitors with monitoring visits, remote source data verification, and reporting.
• Oversee the safety data reporting process to ensure that all AEs/SAEs are reported according to the data safety and monitoring plan
• Help with IND initial submissions and annual reports to FDA.
• Coordinate data safety monitoring board meeting organization, and report preparation.
• Foster a spirit of teamwork among functional groups that allows for open exchange of ideas, expeditious conflict resolution, and appreciation for diversity.
• Collaborate with external clients to develop study protocols.

Required Qualifications*

• Master's Degree in Health Science or an equivalent combination of related education and experience is necessary.
• 6 years of directly related experience in clinical research and clinical trials in the role of project manager.
• An understanding of ICH, GCP and FDA regulations and guidelines with regard to the conduct of human subject research
• Ability to independently perform tasks free from immediate direction.

Work Locations

This is primarily a remote work position. Pending travel restrictions, you may be required to travel within the United States (and possibly internationally) up to 25% to participate in clinical sites and investigator meetings.

Additional Information

In addition to a career filled with purpose and opportunity, The University of Michigan offers a comprehensive benefits package to help you stay well, protect yourself and your family, and plan for a secure future. For more information, please visit: https://careers.umich.edu/benefits/.

Background Screening

The University of Michigan conducts background checks on all job candidates upon acceptance of a contingent offer and may use a third party administrator to conduct background checks. Background checks are performed in compliance with the Fair Credit Reporting Act.

Application Deadline

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 anytime after the minimum posting period has ended.

U-M EEO/AA Statement

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