Associate Director for Clinical Trial Operations and Workforce Development

The Medical College of Wisconsin•Milwaukee, WI

10d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

Master’s degree in a related field preferred (e.g., Health Administration, Clinical Research, or equivalent)
Academic Medical/Research Environment

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.

Benefits

Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental.
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.