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

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.