Research Program Manager I - Department of Medicine

Medical College of Wisconsin•Milwaukee, WI

About The Position

The Research Program Manager I independently manages the activities of a department-wide clinical research program under the direction of the Program Manager II, Vice Chair for Clinical Research, or Executive Administrator. The role oversees daily research staff operations and provides trial support as needed. It gives staff clear direction, mentorship, and operational guidance to align work with institutional research priorities and CTO program goals and operating models. This includes setting expectations, communicating strategic objectives, supporting decision-making, removing barriers, providing regular feedback, supporting skill development, and fostering accountability, collaboration, continuous improvement, and open communication. The position manages program timelines, trial budgets, staff effort, schedules, and resources; supports staff recruitment and training; develops program materials and resources; and oversees program data collection, analysis, dissemination, and reporting. It maintains program databases and files, produces reports on activation timelines, enrollment, financial performance, and compliance, and organizes meetings, site visits, and events. The role serves as a content expert for institutional regulatory platforms, supports staff with systems and processes, and ensures compliance with institutional and regulatory policies. It also liaises with institutional partners, communicates institutional changes to investigators and staff, participates in relevant committees and training, and performs other duties as assigned. The work requires knowledge of clinical trial operations, activation, and regulatory requirements, including ICH-GCP, FDA, and IRB requirements, as well as proficiency with clinical trial management systems and data-driven reporting. The position calls for change leadership, customer focus, trust-building, communication, critical thinking, and influencing skills. A bachelor’s degree and six years of experience are required; appropriate experience may substitute for education on an equivalent basis. Clinical research certification through ACRP or SoCRA is preferred, as is experience in clinical trial management, study activation, regulatory oversight, team leadership and development, staff training, problem solving, research platforms, and trial budget management. Work is performed in an environmentally controlled environment, with occasional exposure to dust, noise, temperature changes, or water and other liquids. The role may occasionally require lifting moderate-weight materials, and may involve standing or walking continuously. It requires the ability to detect and translate speech or other communication; occasionally, distinguishing colors and perceiving relative distances between objects may be required. MCW describes its organizational values as Caring, Collaborative, Curiosity, Inclusive, Integrity, and Respect, and states a commitment to an inclusive environment and equal opportunity without discrimination or harassment based on protected characteristics.

Requirements

Bachelor’s degree; appropriate experience may substitute for education on an equivalent basis.
At least six years of experience.
Knowledge of technical, business, consultation, project management, and cultural awareness.
Working knowledge of clinical trial operations, activation, and regulatory requirements, including ICH-GCP, FDA, and IRB requirements.
Proficiency with clinical trial management systems and data-driven reporting.
Change leadership ability to guide teams through new systems and standardized processes.
Customer focus, trust-building, communication, critical thinking, and influencing skills.
Ability to occasionally lift moderate-weight materials and to stand or walk continuously.
Ability to detect and translate speech or other communication.

Nice To Haves

Clinical research certification through ACRP or SoCRA.
Clinical trials management experience, including managing complex study portfolios.
Study activation experience, including budget and regulatory start-up.
Regulatory knowledge and compliance oversight experience.
Leadership and team development experience.
Staff training, onboarding, and education experience.
Problem-solving and conflict-resolution experience.
Familiarity with research platforms such as OnCore, Florence, and TrialConnX.
Strong trial budget management.

Responsibilities

Manage department-wide clinical research program activities independently under the direction of the Program Manager II, Vice Chair for Clinical Research, or Executive Administrator.
Oversee daily operations of research staff and provide trial support as needed.
Set expectations, communicate strategic objectives, support decision-making, remove barriers, provide feedback, facilitate skill development, and foster accountability, collaboration, continuous improvement, and open communication.
Maintain program timelines and track deadlines for program deliverables.
Manage trial budgets and staff effort; schedule personnel and assess resources.
Assist with staff recruitment and train staff and faculty.
Coordinate development of program materials, including educational materials, guidelines, processes, forms, and reports.
Oversee collection, analysis, and dissemination of program data.
Develop, implement, and maintain program databases and files.
Produce regular reports on activation timelines, enrollment, financial performance, and compliance for program stakeholders.
Organize internal and external meetings, site visits, and special events.
Participate in training for program participants.
Serve as a content expert for institutional regulatory platforms, including OnCore, eBridge, and Florence.
Ensure program data and progress are reported to stakeholders.
Ensure compliance with regulatory and institutional policies, including requirements related to research platforms.
Train and support staff on systems and processes.
Develop program resources through literature searches, contact with outside programs, and review of funding opportunities.
Participate in committees relevant to the program and the profession or research area.
Serve as a liaison to institutional partners.
Communicate institutional changes to investigators and staff and support adoption.
Perform other duties as assigned.

Benefits

Health, vision, and dental coverage.
Flexible Spending options.
403B retirement package.
Competitive vacation and paid holidays.
Tuition reimbursement.
Paid parental leave.
Employee & Family Assistance Program (EFAP).
Pet insurance.
On-campus fitness facility with onsite classes.
Discounted rates on select cell phone plans, local fitness facilities, Milwaukee recreation, and entertainment.