Admin Manager Inter Healthcare

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.

The Michigan Institute for Clinical & Health Research (MICHR) is the home of the University of Michigan’s Clinical and Translational Science Award from the National Institutes of Health. MICHR is part of a national, collaborative consortium that is focused on bringing more health solutions to all people more quickly by advancing translational science. The field of translational science aims to build an evidence base of scientific and operational approaches that improve the efficiency, effectiveness, and impact of translational research across a range of diseases and conditions.

MICHR has the unique charge of examining the translational research ecosystem at a systems level to determine where common pitfalls exist; developing novel solutions to these challenges; demonstrating their effectiveness; and disseminating improvements widely. MICHR is a dynamic organization that serves as a hub of innovation and experimentation to advance research in the science of translation and accelerate the realization of interventions that improve human health.

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.

• Responsible for providing leadership and professional expertise or services to customers and MIAP and SMM staff through knowledge and skills or leveraging the skills of others;
• Manages daily operation of the MIAP and SMM teams. Establishes operational objectives and assignments, and appropriately delegates assignments to subordinates.
• Uses independent judgment when making decisions, assesses work load, work complexity, outcome results and collaborates with other programs or departments when making recommendations that may significantly impact others. Searches out appropriate course of action within the context of policies and procedures that support appropriate decision making.
• Helps set and is guided primarily by established policies, precedents and professional knowledge and/or by projects/program objectives established by deans, directors, chairs, or other (divisional) leadership.
• Recommends program strategic direction and provides leadership in the operational changes for MIAP and SMM. Demonstrates an understanding of how the program(s) fit into the established goals of the University.
• Contributes to the overall strategy, direction and vision for all functional areas of responsibility.
• Has measurable impact on operational effectiveness, attainment of department/unit objectives, service to customers and attainment of research goals.
• Create and Maintains IND/IDE/Monitoring SOPs, standard practice documents, tools, and templates
• Active Membership in national regulatory support professional organizations.

• Manage and oversee UM Sponsor-Investigator FDA approvals for clinical research projects involving drugs, devices, or biologics including INDs and IDEs
• Author, prepare and contribute to IND and IDE filings, pre-submission requests, meeting packages, responses to FDA inquiries, and life‑cycle maintenance submissions to FDA
• Communicate with the FDA regarding regulatory submissions, meeting requests, and other topics
• Provide regulatory guidance, strategy and expertise to UM sponsor‑investigators and study teams
• Critically review clinical protocols, eResearch applications, informed consents, and other documents to ensure compliance with regulatory requirements

• Human resource management duties include interviewing, selecting and training of employees; setting and adjusting their rates of pay and hours of work; planning and directing their work; appraising their productivity and efficiency for the purpose of recommending promotions or other changes in their status; handling their complaints and grievances and disciplining them when necessary.
• Management responsibilities include the authority to hire, fire, salary changes, performance coaching, training and development or promote assigned employees or make recommendations that are given particular weight. Ensures consistent application of organizational and departmental policies, etc.
• Completes performance evaluations and conducts performance reviews.

• Assumes financial responsibility for MIAP/SMM in budget preparation, execution, justifications, and reconciliation. Demonstrates the ability to manage…