SCHARP Leadership

As executive director, Dr. Peter Guarino manages overall operations and provides leadership, direction and oversight to SCHARP and SCHARP’s SMT. He partners with Fred Hutch faculty and Statistical and Data Management Center (SDMC) researchers to set SCHARP’s strategic goals to ensure the clinical trials SCHARP supports are managed according to the highest quality standards.

Prior to joining Fred Hutch in 2015, Guarino spent 15 years with the Department of Veterans Affairs Cooperative Studies Program Coordinating Center in West Haven, Connecticut, where he served for five years as director. He is also an associate clinical professor of biostatistics at Yale University School of Public Health.

“I am committed to maintaining SCHARP’s reputation as a globally recognized statistical and data management center. I’m also dedicated to fostering a rewarding and inspiring workplace environment that develops and empowers staff, promotes a healthy work-life balance and is mission focused.”

Jason Walton serves as SCHARP’s managing director and is responsible for strategic planning, business operations, organizational health, and learning and development.

Walton brings over 20 years of global health and systems thinking to organizational performance and operational management. 

“I help build a highly engaged workforce, and want our staff to realize their full potential, and the organization to be a world-class statistical and data management center that directly contributes to addressing the most pressing global health challenges confronting the world today.” 

Amber Randall provides strategic and organizational management and oversight for a team of dedicated statistical research associates and statistical programmers. She works to foster and promote the operational effectiveness of data analytics through the identification and integration of new technologies, efficient processes and industry-accepted standards.

Randall works closely with the SCHARP SMT to contribute to the advancement of SCHARP and long-term development of the Data Analytics team through the integration of inclusive and humanistic management strategies and empowerment of her team to turn their strengths and passions into practice.

“Our Data Analytics team at SCHARP is uniquely positioned to meld analytics best practices from industry with an academically driven creative exploratory approach. We value diversity in background, experience and ideas to propel a high impact scientific strategy that advances global health efforts.”

Kristine Donaty provides strategic, organizational and operational management and guidance to SCHARP’s Clinical Data Management unit, a dedicated team of clinical data managers, coordinators, electronic data capture (EDC) system programmers and clinical programmers.

Donaty works to foster and promote the long-term development of this unit in close collaboration with team managers and staff who support the progression of clinical trials from implementation to closeout. She helps ensure that the clinical data management services for SCHARP meet all protocol and regulatory requirements.

“I am committed to a humanistic approach to leadership by fostering an inclusive and collaborative environment that produces innovative data management solutions for the team to meet the protocol and regulatory needs of our clinical trials.”

As director of Clinical Coding and Safety, Elaine Dinnie provides strategic, organizational and operational management, leadership and guidance to SCHARP’s dedicated team of clinical safety associates and clinical coding specialists.

Her role includes providing subject matter expertise, as well as ensuring that the SCHARP Clinical Coding and Safety unit services meet all regulatory requirements. Dinnie also collaborates with stakeholders, including protocol safety teams, sponsors and regulatory bodies, to ensure safety standards are maintained throughout the clinical trials process.

“I am committed to upholding the highest standards of safety, data integrity and regulatory compliance in the conduct of clinical trials. I am equally dedicated to fostering the long-term development of my team by promoting a culture of excellence in clinical safety practices. Through these efforts, we aim to enhance global health outcomes and contribute to the advancement of available medical treatments.”

Bhavesha O’Byrne provides strategic, organizational and operational leadership and mentorship to a dedicated and highly skilled team of lab data managers, coordinators, lab programmers, Python programmers and program managers. She collaborates with the SCHARP SMT, SDMC leadership and other stakeholders to optimize lab data management processes and infrastructure.

“With more than two decades of experience in clinical trials, my work philosophy is firmly based on a dedication to excellence, integrity, adaptability and innovation in enhancing global health outcomes. I strive to uphold SCHARP’s commitment to a mission-driven positive workplace by promoting a culture of respect, recognition, diversity and inclusion.”

As director of Quality Assurance, Gisele Desrochers provides guidance, supervision and oversight of SCHARP’s comprehensive Quality Management System (QMS) which includes regulatory compliance and managing a Trial Master File (TMF) program.

As a member of the SMT, she helps formulate strategies, infrastructure, policies and standards for the Quality Assurance department and across SCHARP, aligning these with SCHARP's vision, mission and goals and ensuring the program meets industry standards and regulatory requirements.

Desrochers also serves as the main contact for regulatory inspections and third-party client audits.

“I am committed to continuously enhancing our Quality Assurance program. My focus is on finding opportunities to improve the efficiency of our processes and to incorporate risk-based methods where able, while ensuring that we meet client expectations, adhere to industry best practices and comply with regulatory requirements.”

Matthew Martin manages SCHARP’s Technology Systems & Services team, which is responsible for system engineering and development, support and operations and administration within SCHARP’s technical infrastructure.

Martin also oversees enterprise data management operations and provides technical leadership and guidance on long-term strategic planning, technology roadmap development and day-to-day technical operational. During his tenure at SCHARP, he has aligned SCHARP IT operations with industry best practices and implemented several technology systems that expand capability and improve efficiencies.

"I am committed to supporting a highly engaged and inclusive team of professionals focused on innovation through technical excellence and collaboration where every voice matters and everyone has the opportunity to contribute and grow.”