Godfrey Nyakaya is a senior clinical research professional with over 16 years of experience in clinical trials across Africa, with specialized expertise in quality assurance, site monitoring, and regulatory compliance. He holds a Master of Science in Clinical Trials from the London School of Hygiene and Tropical Medicine and has built a strong track record in delivering GCP-compliant, audit-ready research across multi-country studies.
He has held key roles with leading global research organizations, including Drugs for Neglected Diseases initiative, GlaxoSmithKline, and the KEMRI-Wellcome Trust Research Programme. Across these roles, he has led clinical trial monitoring, quality system development, regulatory inspection readiness, and risk-based quality management, supporting studies from initiation through close-out.
Godfrey brings deep technical expertise in ICH-GCP, GCLP, and ISO-aligned quality systems, with hands-on experience in audit planning, CAPA implementation, deviation management, and trial master file (TMF) oversight using platforms such as Veeva eTMF. He has also played a critical role in strengthening laboratory and clinical trial quality systems, contributing to GCLP accreditation and ISO 9001-certified processes.
In addition to his operational expertise, he is actively engaged in advancing global quality standards as a Group Leader for GCLP review with the Oxford Global Health Network, contributing to the development of risk-based quality management frameworks and training materials aligned with evolving regulatory expectations.
Within Amyloidosis Africa, Godfrey leads the development of clinical research quality and compliance frameworks, ensuring that all research activities meet international standards and are aligned with trial readiness requirements. His role is central to bridging the gap between awareness initiatives and high-quality, multi-country clinical research, positioning the network for credible collaboration with global partners and sponsors.
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