Clinical Research Manager

at  University of WisconsinMadison

JOB SUMMARY:

The Clinical Research Manager is responsible for leading the clinical research program and the Office of Clinical Research (OCR) in the UW Madison Department of Surgery (DOS) and reports directly to the Director of Research Operations. The OCR provides full-service study coordination and regulatory services for industry, extramurally and government funded, as well as investigator-initiated interventional studies including drug and device trials. This position will work closely with department leadership including the Director of Research Operations and Vice Chairs of Research and with key collaborators outside of the department including the Clinical Trials Institute.

The Clinical Research Manager will:

• Lead the growth, innovation, process improvement, and sustainability for the OCR and the clinical research program
• Ensure compliant and high-quality clinical research
• Facilitate relationships with the Clinical Trials Institute, clinical providers in multiple care areas (ICU, emergency department, operating room, etc.), industry sponsors, faculty, residents, staff, and research trainees

This position will provide day-to-day oversight and support to the OCR including:

• Managing the portfolio of studies, establishing policies and procedures, and managing the OCR budget and finances
• Supervising a clinical research supervisor and research program coordinator
• Collaborating with the Clinical Trials Institute on regulatory services provided for department research, such as IRB submissions, FDA submissions, and internal and external audit and inspection management.
• Providing direction and issue resolution for study-related concerns and risks.

The clinical research coordinator team provides 24/7 on-call coverage through a balanced on-call model. The Clinical Research Manager may need to be available to be periodically contacted outside normal hours to support on-call staff and activities.

EDUCATION:

Preferred
Bachelor’s Degree in business administration, biological sciences, or health-related field

QUALIFICATIONS:

Required Qualifications

• Experience coordinating clinical research
• Experience leading teams

Preferred Qualifications

• Experience in coordinating pharmaceutical, device and/or biological products
• Experience with regulatory services including IRB submissions and FDA submissions
• Experience conducting clinical research in an academic medical center

An ideal candidate will be:

• Very knowledgeable about current clinical research regulations and good clinical practices
• A proven team leader with exemplary skills in process/change management
• A highly skilled mentor and communicator able to engage professionally with a wide variety of individuals
• A problem solver, highly collaborative, adaptive, proactive, and committed to creating a positive work environment that is transparent, cooperative, and trusting.

Plans, develops, and directs a clinical research program within a division, center, or department. Solicits clinical research opportunities, develops policies and procedures, and has significant responsibility for the overall functioning and effectiveness of the clinical research. Supervises clinical research staff.

• 20% Plans staff implementation of protocols and on-going quality review of one or multiple, basic or moderately complex clinical research trials or programs
• 25% Analyzes research portfolios and accounts, solicits internal and external research opportunities, promotes unit capabilities, and makes recommendations to leadership for strategic program enhancements
• 10% Compiles audits and documents research data to ensure necessary compliance with institutional policies and procedures
• 5% Composes, assembles, and submits grant proposals and protocols according to applicable rules and regulations
• 15% Exercises supervisory authority, including hiring, transferring, suspending, promoting, managing conduct and performance, discharging, assigning, rewarding, disciplining, and/or approving hours worked of at least 2.0 full-time equivalent (FTE) employees
• 5% Develops and monitors the program budget; and reviews and approves expenditures
• 10% Collaborates with UW Health, SMPH leadership, and Department leadership to support department and institutional clinical trial strategic goals
• 5% Interfaces with clinical providers to support 24/7 activities across phases of care
• 5% Provides faculty mentorship, development, and guidance related to clinical research including feasibility assessments and consultations for new projects