Summary

Work independently, under the direction of the Program Manager II, Vice Chair for Clinical Research, or Executive Administrator to manage the activities of a department-wide clinical research program. Oversee daily operations of research staff and engage in trial support as needed. Provide clear direction, mentorship, and operational guidance to research staff to ensure alignment with institutional research priorities and CTO program goals and operating model. This includes setting expectations, communicating strategic objectives, supporting decision‑making, and proactively removing barriers to progress. Promote a culture of accountability, collaboration, and continuous improvement by offering regular feedback, facilitating skill development, and fostering open communication across the team.

Primary Responsibilities

• Maintain program timelines including tracking deadlines for program deliverables.
• Management of trial budgets and staff effort. Schedule people and assess resources.
• Assist with staff recruitment and training of staff & faculty
• Coordinate the development of program materials including educational materials, guidelines, processes, forms, and reports.
• Oversee the collection, analysis, and dissemination of program data. Develop, implement, and maintain databases and files. Produce regular reports on activation timelines, enrollment, financial performance, and compliance for program stakeholders.
• Develop, implement, and maintain databases and files related to the program.
• Organize internal and external meetings, site visits, and special events.
• Participate in training for programs participants.
• Serve as content expert for institutional regulatory platforms (i.e., OnCore, eBridge, Florence)
• Ensure program data and progress are reported to program stakeholders.
• Ensure compliance with regulatory and institutional policies, including research platforms. Train and support staff on systems and processes
• Participate in the development of program resources through literature searches, contact with outside programs, and review of funding opportunities.
• Participate in appropriate committees relevant to the advancement of the program and the profession or area of research.
• Serve as a liaison to institutional partners. Communicate institutional changes to investigators and staff and suporrt adoption.
• Other duties as assigned.

Knowledge – Skills – Abilities

• Knowledge of technical, business, consultation, project management, and cultural awareness.
• Working knowledge of clinical trial operations, activation, and regulatory requirements (e.g., 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, building trust, communication, critical thinking, and influencing skills

Qualifications

Appropriate experience may be substituted for education on an equivalent basis.

Minimum Required Education: Bachelor’s degree

Minimum Required Experience: 6 years

Preferred Certification/Licensure(s): Certified in Clinical Research through ACRP or SoCRA

Preferred Experience:

• Clinical trials management, including ability to manage complex study portfolios
• Study activation experience, including budget and regulatory start-up
• Regulatory knowledge / compliance oversight
• Leadership / Team development
• Staff training, onboarding, education
• Problem solving / conflict resolution
• Familiarity with reserach platforms e.g., OnCore, Florence, TrialConnX
• Strong trial budget management

Physical Requirements

Work requires occasionally lifting moderate weight materials, standing, or walking continuously.

Work Environment

Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environment.

Sensory Acuity

Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects.

#LI-AC1

Why MCW?

• Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options
• 403B Retirement Package
• Competitive Vacation and Paid Holidays offered
• Tuition Reimbursement
• Paid Parental Leave
• Employee & Family Assistance Program (EFAP)
• Pet Insurance
• On campus Fitness Facility, offering onsite classes
• Additional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.

For a brief overview of our benefits see: Benefits Overview

For a full list of positions see: MCW Careers

At MCW all of our endeavors, from our internal operations to our interactions with our partners, are driven by our shared organizational values: Caring – Collaborative – Curiosity – Inclusive – Integrity – Respect. We are committed to fostering an inclusive environment that values diversity in backgrounds, experiences, and perspectives through merit-based processes and in alignment with all applicable laws. We believe that embracing human differences is critical to realize our vision of a healthier world, and we recognize that a healthy and thriving community starts from within. Our values define who we are, what we stand for and how we conduct ourselves at MCW. If you believe in embracing individuality and working together according to these principles to improve health for all, then MCW is the place for you. For more information, please visit our institutional website.

MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination:

The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering an inclusive community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic.