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Summary

The Associate Director for Clinical Trial Operations 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

Required
Certification/Licensure(s): Clinical Research Coordinator Certification

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.

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Classification

FLSA
Status Exempt

FLSA Test Administrative

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:

For a full list of positions see: