Director, Clinical Trial Activation & Quality Office - Research Office

Director, Clinical Trial Activation & Quality Office

The Medical College of Wisconsin (MCW) is advancing an enterprise-wide transformation of clinical trial activation designed to reduce unnecessary delays, strengthen quality, improve transparency and accountability, and make it easier for investigators to bring promising studies to patients and research participants.

The Director, Clinical Trial Activation & Quality Office, provides senior operational leadership and strategic direction for the development, growth, and sustainability of the enterprise clinical trials portfolio. The Director will have a unique opportunity to oversee an integrated activation team and shape the systems, data, quality framework, and operating model that support MCW's growing clinical research portfolio.

The Director is a vital contributor and subject matter expert across the research mission, liaising with research leadership and the leadership of clinical partners to help steer strategic decision making, as well as developing strong partnerships with internal and external stakeholders as it relates to the operation and execution of efficient clinical trial activation and overall quality.

Reporting to the Assistant Dean, Research Operations, the Director serves as the primary operational advisor to Office of Research leadership on activation performance, quality, infrastructure, and emerging risks. The Director works across the Office of Research, academic departments, clinical partners, and other institutional functions to establish shared accountability, resolve barriers, and improve the end-to-end activation experience.

The Director leads the Activation and Quality Office, overseeing the clinical trials budget development team, managing infrastructure needs, and ensuring high-quality operations. The Director plays a critical role in measuring data-driven goals, ensuring standardization and transparency along the activation pipeline.

• Lead MCW's centralized clinical trial activation function, creating an integrated, transparent, and accountable approach to advancing studies from initial intake and feasibility through budget, contract, regulatory, ancillary review, and activation, interfacing with other institutional units and partners providing activation support.
• Direct program development, strategy, organizational development, long range planning, change management, and implementation of the infrastructure, processes and systems necessary to scale efficient, safe, and high-quality clinical trials at MCW.
• Develop and monitor data-driven metrics to ensure efficient clinical trial activation, organizational transparency, stakeholder accountability, and opportunities for enhancement and improvement.
• Analyze activation performance against institutional goals and national benchmarks to identify delays, recurring bottlenecks, variation across departments and study types, and opportunities for improvement; translate findings into recommendations for corrective action.
• Identify, clarify, and resolve strategic impact issues with college wide impact which may span multiple areas, using advanced clinical trials and Good Clinical Practice knowledge requiring broad discretion and judgement.
• In partnership with key stakeholders, assess and guide enterprise clinical trials infrastructure, including staffing levels, applications and software, and other items of organizational or fiscal impact.
• Lead, develop, and mentor the Quality Office function; establish clear roles, service expectations, performance standards, and a culture of collaboration, accountability, continuous learning, and responsive support.
• Oversee the operation of the centralized clinical trial budget development team.
• Ensure ongoing compliance and adherence to quality standards and federal and institutional policies, monitoring and addressing issues and mitigating risks.
• Participate on appropriate committees relevant to the advancement of the MCW clinical trials portfolio, and serve as a subject matter expert and liaison with institutional leaders, administration, faculty, other departments, affiliates, outside institutions, and national…