khomananihrc

Nyeleti Mthombeni

Sub-Investigator

Background: Ms Nyeleti Mthombeni is a highly qualified and experienced clinical research
professional with a strong academic background in pharmacology and project
management. She completed her MSc in Pharmacology from Sefako Makgatho Health
Sciences University in 2014 and holds an MSc in Project Management from the University of
Pretoria, obtained in 2012. Nyeleti also has a BSc Honours in Biochemistry and a BSc degree
from Sefako Makgatho Health Sciences University, demonstrating her solid foundation in
the biomedical sciences.


Professional Experience: Nyeleti brings over 17 years of experience in clinical research and
quality assurance across various roles and organisations. She is currently a Quality
Assurance and Capacity Development Consultant at PPMR and a Clinical Research Service
Consultant at Afrileadtech Research. Her extensive experience includes serving as Clinical
Operations Director at OnQ Research, Regional Study Manager and Clinical Project Lead at
Sanofi Aventis, and several other key roles at renowned pharmaceutical companies like
Novartis, Pfizer, and Novo Nordisk. Nyeleti has also worked with the Medicines Control
Council (MCC) of South Africa, further deepening her regulatory expertise.


Clinical Research Contributions: Throughout her career, Nyeleti has played pivotal roles in
numerous clinical trials. Her recent work includes being a Clinical Research Associate for
studies on invasive pulmonary aspergillosis and candidiasis, a Project Manager for a
COVID-19 vaccine study, and a Study Coordinator and Quality Lead for a phase 3 study
assessing the efficacy of the Ad26.COV2.S vaccine for the prevention of COVID-19. Nyeleti
has also managed regional projects in the fields of asthma and cardiovascular outcomes,
showcasing her ability to handle complex clinical trials across diverse therapeutic areas.


Role at Khomanani Research Centre: As a Sub-Investigator at Khomanani Research
Centre, Nyeleti contributes her vast experience and expertise to the successful conduct of
clinical trials. Her role involves overseeing the implementation of study protocols, ensuring
compliance with Good Clinical Practice (GCP) guidelines, and supporting the overall quality
and integrity of the research.


Vision: Nyeleti is committed to advancing clinical research in South Africa, particularly in
areas that address pressing public health challenges. Her goal is to continue contributing
to the development of safe and effective medical interventions through rigorous research
and quality assurance.