Associate Director for Clinical Trial Operations and Workforce Development

Summary

The Associate Director for Clinical Trial Operations and Workforce Development provides strategic and operational leadership for clinical trial activities within the Clinical and Translational Science Institute (CTSI) at the Medical College of Wisconsin (MCW). This position oversees the CTSI Clinical Trials Office and the Adult Translational Research Unit (A-TRU), ensuring excellence in clinical research operations, compliance, and staff development.

The incumbent will build and lead systems that promote transparency, accountability, and efficiency in clinical research conduct. They will collaborate with institutional and national partners to advance MCW’s clinical research enterprise by reducing trial activation times, enhancing operational quality, and ensuring alignment with NIH and MCW policies. This individual will serve as an architect and catalyst for institutional improvement in clinical trial processes—developing dashboards, standard operating procedures (SOPs), educational resources, and performance metrics to strengthen the overall clinical trial portfolio at MCW.

Primary Responsibilities

• Provide strategic direction and operational leadership for the CTSI Clinical Trials Office and Adult Translational Research Unit.
• Supervise clinical trial operations staff, ensuring alignment with MCW’s mission, policies, and NIH guidelines.
• Foster a culture of continuous improvement, collaboration, and accountability in clinical trial operations.
• Ensure high-quality, compliant, and efficient conduct of clinical trials across MCW research sites.
• Oversee adherence to institutional, NIH, FDA, and other regulatory requirements related to human subjects research.
• Develop and implement SOPs, quality metrics, and monitoring processes to promote compliance and operational integrity.
• Lead the design and implementation of CTSI training and credentialing programs for clinical research staff across the consortium.
• Coordinate hiring and milestone achievement for promotion for clinical research staff.
• Develop and disseminate educational materials and resources to support staff competency and professional growth.
• Establish systems for continuous learning, best practice sharing, and workforce development across clinical research teams.
• Design and maintain systems to measure, report, and optimize clinical trial performance.
• Develop dashboards and analytical tools to track trial activation, enrollment, and compliance metrics.
• Implement transparent reporting mechanisms to inform leadership decision-making and resource allocation.
• Provide financial oversight for the CTSI Clinical Trials Office and A-TRU.
• Ensure efficient resource utilization, budget management, and cost recovery across operational areas.
• Collaborate with institutional finance partners to support sustainable growth and operational efficiency.
• Partner closely with the CTSI Managing Director, and Director, and Senior Associate Directors to align operational strategies with the broader CTSI mission and CTSA grant objectives.
• Engage with key institutional stakeholders—including investigators, department leaders, and compliance offices—to strengthen clinical trial infrastructure.
• Represent MCW and the CTSI in local and national discussions on clinical trial management and translational research best practices.

Knowledge – Skills – Abilities

• Demonstrated success in building systems that improve trial activation timelines, operational efficiency, and data transparency.
• Deep understanding of NIH, FDA, and GCP compliance standards.
• Proven ability to lead cross-functional teams and foster a collaborative research culture.
• Experience with financial oversight and performance-based management of research operations.
• Strong analytical, strategic planning, and communication skills.
• Understanding of financial and human resources related issues.
• Excellent project management skills.
• Excellent oral and written communication skills (interpersonal, customer focus).
• Strong critical thinking, problem solving and attentiveness to detail required.
• Ability to build/foster strong, trusting relationships.

Qualifications

Appropriate experience may be substituted on equivalent basis.

Minimum Required Education:        Bachelor’s Degree

Minimum Required Experience:      Minimum of 7 years of progressive experience in clinical research operations, with leadership responsibility in a complex academic or health system environment.

Preferred Education:                           Master’s degree in a related field preferred (e.g., Health Administration, Clinical Research, or equivalent)

Preferred Experience:                 Academic Medical/Research Environment

Physical Requirements

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

Work Environment

Little or no exposure to hazards such as dust, fumes, or extreme temperatures, airborne or blood borne pathogens, extreme temperatures, or allergens.

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.

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.