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.
Job Summary
The University of Michigan Department of Cardiac Surgery is seeking a highly motivated Project Manager to support the daily activities of a multi-year federally funded research project within the Section of Health Services Research and Quality (HSRQ). The Section of Health Services Research and Outcomes is a nationally recognized leader in advancing clinical and health services research and quality improvement.
The successful candidate will have broad responsibilities and opportunities for continued professional growth. This individual will work with the Principal Investigators to administer and provide oversight of the day-to-day operations of the project including the coordination of study related activities, study team meetings, budget management, resource planning and allocation, procurement of startup supplies, participant recruitment and retention, regulatory & subcontracts management, data collection & management, study visit coordination, sponsor reports. This individual should have strong analytical and oral/written communication skills, as they will actively participate in the development of scientific abstracts and manuscripts. In this role, the Project Senior Manager will work with a highly collaborative group of clinicians, health services researchers, biostatisticians, study team members, regulatory personnel, and other healthcare professionals.
This position offers a flexible work schedule and the ability to work a hybrid schedule or fully remote.
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.
Why Join Michigan Medicine?
Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.
What Benefits can you Look Forward to?
- Excellent medical, dental and vision coverage effective on your very first day
- 2:1 Match on retirement savings
Responsibilities*
Characteristic Duties and Responsibilities:
- Scientific Concepts and Research Design
- Ethical Participant Safety Considerations
- Investigational Products Development and Regulation
- Clinical Study Operations (GCPs)
- Study and Site Management
- Data Management and Informatics
- Leadership and Professionalism
- Communication and Teamwork
Job Specific Responsibilities:
- Under the supervision of the Principal Investigators, manage and support the daily operations of a multi-year, multi-institutional federal grant and serve as the primary point of contact for all project related activities
- Determine project needs, identify resources and develop detailed schedules and work plans based on the stated objectives of the grant
- Participate in the hiring and onboarding of study team members including research professionals, study coordinators, study interns, and other required personnel
- Manage regulatory documents and procure supplies
- Maintain accurate project records by tracking the progress of various study components and documenting the project status
- Manage the project budget and monitor all expenses associated with the administration of the grant
- Coordinate the collection of research data and record information in study documents, forms and electronic research databases
- Provide regulatory support for various forms of documentation including Institutional Review Board (IRB) submissions, study protocols, study amendments, adverse event reports, data query resolutions, quality assurance reports, annual continuing reviews, and study close outs
- Generate progress reports for regularly occurring study coordination meetings, consortium meetings, and funding applications and reports
- Organize and conduct various project meetings including committee meetings, team meetings and study coordinator meetings
- Draft, edit and review scientific abstracts and manuscripts, and manage the submission process to peer-reviewed journals
- Serve as the primary project liaison between study subjects, investigators, other departments, external sites, sponsors, and regulatory agencies
- Assure compliance with protocols, adherence to good clinical practice guidelines, sponsor regulations and all other federal, local and University guidelines
- Provide mentorship to other staff with regard to clinical research best practices and policies
- Other duties as assigned or required for the research project
Required Qualifications*
- Bachelor's degree in a health-related field or regulatory-related field
- Evidence of excellent scientific writing skills
- Strong interpersonal communication skills
- Flexibility and ability to solve problems and make decisions within the scope of position responsibilities
- Strong administrative and organizational skills including the ability to work well under time constraints to meet deadlines
- Strong computer skills including proficiency in Microsoft software applications
- Strong ability to manage and oversee multiple ongoing projects within the grant
- Strong ability to identify barriers and propose alternative strategies to achieve desired outcomes
- Flexibility and ability to work independently and collaboratively with researchers, faculty, patients, and families in a diplomatic and effective manner
Senior level: More than 4 years of experience.
Intermediate Level: 2 - 4 years related experience.
Desired Qualifications*
- Master?s degree in Public Health
- Experience with conducting statistical analyses
- 3-5 years of directly related experience in clinical research
- Experience coordinating multi-center clinical research
- Experience in the regulatory aspect of clinical research management
- Familiarity with cardiac surgery or related clinical settings
- Experience with the U-M eResearch Regulatory Management and Proposal Management systems, REDCap
Modes of Work
Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.
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. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
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.