Clinical Research Manager

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.

Responsibilities:

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

Institutional Statement on Diversity:

Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals. The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world. For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion

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.

Work Type:

Full or Part Time: 80% - 100% This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location.

Appointment Type, Duration:

Ongoing/Renewable

Salary:

Minimum $80,000 ANNUAL (12 months)
Depending on Qualifications
The starting salary for the position is $80,000 but is negotiable based on experience and qualifications. Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. Benefits information can be found at ().

Additional Information:

This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years. The successful applicant will be responsible for ensuring eligibility for employment in the United States on or before the effective date of the appointment. University sponsorship is not available for this position. The department will not be able to support a request for a J-1 waiver. If you chose to pursue a waiver and apply for our position, neither the UW nor UWMF will reimburse you for your legal or waiver fees.

How to Apply:

To apply for this position, please click on the "Apply Now" button. You will be asked to upload a current resume/CV and a cover letter briefly describing your qualifications and experience. You will also be asked to provide contact information for three (3) references, including your current/most recent supervisor during the application process. References will not be contacted without prior notice.

Contact:

Samantha Connell


Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Official Title:

Clinical Research Manager(RE018)

Department(s):

A53-MEDICAL SCHOOL/SURGERY/RESEARCH ADMIN

Employment Class:

Academic Staff-Renewable

Job Number:

295754-AS

The University of Wisconsin-Madison is an Equal Opportunity and Affirmative Action Employer.

Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence through diversity and encourage all qualified individuals to apply. If you need to request an accommodation because of a disability, you can find information about how to make a request at the following website: Employment will require a criminal background check. It will also require you and your references to answer questions regarding sexual violence and sexual harassment. The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7). The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department .

About University of Wisconsin Madison

The University of Wisconsin–Madison has been a catalyst for the extraordinary since its founding in 1848. Our students, staff, and faculty partake in world-class education and conduct prolific research that solves real-world problems. Our guiding principle is the Wisconsin Idea, a commitment to outreach that creates a better future for our state, our nation, and the world. We value the contributions of each person and recognize that diversity is a source of strength, creativity, and innovation.

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