Godfrey Tuda Otieno
Summary
A proven and performance-driven Clinical Trials Laboratory Scientist with over 23 years of progressive experience in leadership and streamlining complex laboratory operations across diverse research settings. Skilled in the development and maintenance of robust Quality Management Systems (QMS), including ISO 15189 and GCLP accreditations, which significantly improved laboratory standards and effectiveness. Experienced in establishing high-performing teams, efficient resource management, and effective stakeholder engagement to produce accurate and timely outcomes for clinical trials and epidemiological studies. Committed to advancing scientific knowledge through meticulous laboratory practice, data integrity, and cross-disciplinary research initiatives.
Overview
27
27
years of professional experience
1
1
Certification
Work History
Clinical Laboratory Scientist
London School of Hygiene and Tropical Medicine
07.2018 - Current
- Managing Clinical Chemistry, Sample Reception, and Biorepository laboratories. Assumed Laboratory Manager responsibilities during absences.
- Directed GCLP laboratory accreditation, significantly enhancing laboratory quality and upholding total compliance for critical vaccine trials.
- Organized 100% on-time participation in proficiency-testing programs, ensuring continuous quality assurance and prompt correction of deficiencies to guarantee reliability and precision of generated results.
- Directed comprehensive equipment inventories and maintenance plans, scheduling replacements to meet shifting study needs while avoiding downtime on multiple research studies.
- Organized shipments of over 5000 sensitive biological specimens internationally annually, maintaining 100% IATA compliance for hazardous materials, supporting global research collaborations.
- Coordinated implementation and operation of Laboratory Information Management Systems (LIMS) to ensure timely and accurate release of data for over 20 ongoing clinical and epidemiological studies.
- Performed complex safety laboratory assays including Haematology, Clinical Chemistry, and Point-of-Care Testing (POCT) using Gene-xpert, essential in vaccine trials and epidemiological studies.
- Successfully reviewed parasitology survey slide readings, revising initial malaria prevalence from 72% to 39%, leading to a PLoS One publication by Prof. Frank Baiden.
- Conceived and implemented a RedCap database for malaria slide outcome recording, which simplified data cleaning and enabled proper statistical analysis, enhancing research workflow.
- Designed a dedicated WHO-STV database for effective sample management to improve tracking and retrieval of serum, swabs, and DNA aliquots.
- Devised efficient query resolution methods for PREVAC, EBOVAC, and WHO-STV studies, resulting in minimal aliquot loss and positive feedback from sponsors. This earned the site a good name and made us visible.
- Consistently attended and often chaired weekly laboratory meetings, contributing to strategic planning and operations improvement based on input from Principal Investigators and senior management.
- Successfully managed over 10 internal and external audits and monitoring visits, receiving consistent positive feedback and demonstrating strong laboratory quality systems.
- Ensured 100% staff competency through rigorous training programs, enabling laboratory staff to successfully perform their duties.
- Contributed to a successful US FDA inspection.
Laboratory Consultant
RAMS Global Consulting Company
Nairobi
01.2016 - 12.2016
- Enhanced TB diagnostic systems in three regional Tanzanian hospitals (Temeke, Ilala, Mwanyamala) to ISO 15189 standards, resulting in an estimated 20% diagnostic accuracy improvement.
- Achieved ASLM accreditation (+4 stars and ISO 15189 certification) for partner institutions, marking a significant milestone in regional health infrastructure development.
- Performed over 15 quality control audits and risk evaluations that resulted in the effective implementation of new infection control procedures, decreasing biosafety incidents by 15%.
- Trained over 50 laboratory staff on ISO 15189:2012 and quality fundamentals, leading to a 25% increase in data capture and overall work efficiency.
- Developed and delivered over 10 advanced technical reports to MDH, Ministry of Health, and RAMS Global, directly impacting key stakeholder decisions and policy implementation.
Laboratory Supervisor
KEMRI Wellcome Trust Program
Kenya
01.1999 - 07.2016
- Achieved seven GCLP accreditations for Kilifi Wellcome Trust Laboratory since 2010, consistently upholding high working standards essential for clinical trial integrity.
- Instrumental in securing ISO 15189 certification for HIV/Serology Research Laboratories for six consecutive years, demonstrating long-term commitment to international quality standards.
- Validated and certified clinical chemistry systems, making them fit for purpose and contributing to research data reliability and accuracy.
- Achieved 100% availability of all laboratory reagents and consumables, preventing any stock-out incidents in 17 years, thus ensuring uninterrupted research activities.
- Certified by WHO/NICD as the best microscopist for GSK MAL-005, exhibiting unparalleled technical competence in microscopy.
- Coordinated daily laboratory operations in clinical trials, with uncompromising observation of ALCOA+, Q-PULSE, and GCLP guidelines.
- Performed microorganism isolation from Blood and CSF cultures for several research studies, including those by Prof. Antony Scott (Pneumonia), Prof. Jay Berkely (Bacteraemia), Prof. Kathryn Maitland (Malaria Fluid), and Prof. Thomas Williams (Sickle Cell).
- Performed Osmolality testing of breast milk to ascertain nutrition levels in relevant research cohorts.
- Performed CD4/CD8 testing on IAVI samples for Protocol B (Cohort study to determine HIV incidence), C (prospective study of acute HIV infection), and D (cross-sectional study of healthy African adults), consistently providing accurate and reproducible results.
Education
Master of Science - Biomedical Sciences
University of Greenwich
UK04.2023
Bachelor of Science - Medical Laboratory Science
Mount Kenya University
01.2011
Higher National Diploma - Clinical Chemistry
Technical University of Kenya
12.2008
Higher National Diploma - Immunology
Mombasa Technical University
12.2004
Skills
- Quality Management Systems (QMS) installation
- ISO 15189
- GCLP Accreditation
- Quality Control (QC)
- Quality Assurance (QA)
- Internal Audits
- External Audits
- Risk Assessment
- RT-qPCR
- DNA Extraction
- Genotyping
- PCR
- Gel Electrophoresis
- Peripheral Blood Mononuclear Cell (PBMC) Separation
- Cell Viability Testing
- ELISA Assays
- Western Blot
- Clinical Chemistry (automated analyzers)
- Hematology (automated analyzers)
- Point-of-Care Testing (POCT)
- Microbiological Culture & Isolation
- Parasitology (microscopy)
- Laboratory Information Management Systems (LIMS)
- RedCap Database Development
- Data Cleaning
- Basic Statistical Analysis
- International Sample Shipment (IATA Dangerous Goods Regulations)
- Biobanking Principles
- Human Tissue Policy Management
- Infection Control Protocols
- Operating various automated analyzers
- Gene-xpert platform
Certification
- DNA Extraction and Genotyping, 2025
- Human Tissue Policy Management Training - LSHTM, 2025
- Biobanking Training - Institut Pasteur, France, 2025
- RT-qPCR to Quantify DNA and mRNA Levels to Specific Genes, 2024-2025
- IATA Training on Infectious Substances Shipping Guidelines, 2024
- Certificate in Immunology: Vaccines and Viral Immunology – Harvard Medical School, 2024
- Certificate in Genetics: Genetic Testing and Sequencing Technologies – Harvard Medical School, 2024
- Data Visualization for Data Analytics – LinkedIn, 2024
- Peripheral Blood Mononuclear Separation, 2023-2024
- Cell Viability Testing, 2023-2024
- Protection of Human Subjects – Harvard Medical School, 2023
- ELISA Assays, 2023
- Laboratory Systems and Public Health in Resource-Limited Settings (LAB-SPHERE) – BNITM, Germany, 2020
- ISO 15189:2012 and SLMTA Training, 2011-2015
- Leadership and Management in Global Health – University of Washington, 2013
- Good Clinical Laboratory Practice (GCLP) and Good Clinical Practice (GCP), 2000-2025
Kudo Board
https://www.kudoboard.com/boards/WDjKFSbP
Webpage
https://godfreytuda.com/book-appointment/
Languages
- English, Fluent
- Kiswahili, Fluent
- French, Intermediate
- Krio, Intermediate
Publications
- Baiden, F., Otieno, G. T., et al., Managing false positive Ebola Test results in the post-outbreak era: experience in the EBOVAC vaccine Trial in rural Sierra Leone., 2022
- Ishola, D., Otieno, G. T., et al., Safety and long-term immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Sierra Leone: a combined open-label, non-randomized stage 1, and a randomized, double-blind, controlled stage 2 trial., Lancet Infectious Diseases, 22, 1, 97-109, 2022
- Afolabi, M. O., Otieno, G. T., et al., Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in children in Sierra Leone: a randomized, double-blind, controlled trial., Lancet Infectious Diseases, 22, 1, 110-122, 2022
- Choi, E., Otieno, G. T., et al., Vaccine strategies for Ebola virus disease: the PREVAC randomized trial., TBD
- Manno, D., Otieno, G. T., et al., Immunogenicity and safety of a single booster dose of an Ad26.ZEBOV vaccine in previously two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccinated children: an open-label, non-randomised phase 2 trial., TBD
- Baiden, F., Fleck, S., Leigh, B., Ayieko, P., Tindanbil, D., Otieno, T., Lawal, B., Tehtor, M., Rogers, M., Odeny, L., Hodges, M. H., Sonnie, M., Samai, M., Ishola, D., Lowe, B., Watson-Jones, D., & Greenwood, B., Prevalence of malaria and helminth infections in rural communities in northern Sierra Leone, a baseline study to inform Ebola vaccine study protocols., PLoS One, 17, 7, 2022
- Manno, D., Ayieko, P., Ishola, D., et al., Ebola Virus Glycoprotein IgG Seroprevalence in Community Previously Affected by Ebola, Sierra Leone., Emerging Infectious Diseases, 28, 3, 734-738, 10.3201/eid2803.211496, 35202536, 2022
- Ishola, D., & EBOVAC-Salone Malaria Infection (MALI) Sub-Study Team., Asymptomatic Malaria Infection and the Immune Response to the 2-Dose Ad26.ZEBOV, MVA-BN-Filo Ebola Vaccine Regimen in Adults and Children., Clinical Infectious Diseases, 10.1093/cid/ciac209, 2022
References
Available upon request.
Professional Service And Affiliations
- Kenya Medical Laboratory Technician and Technologist Board
- African Society for Laboratory Medicine (ASLM)
- International Papillomavirus Society
- Clinical Research Society of Kenya (Registered awaiting membership)
Locations
- London School of Hygiene and Tropical Medicine, Freetown, Western Area, 00000, Sierra Leone
- Nairobi, Kenya, Nairobi, Nairobi, 00000, Kenya
- Kilifi Wellcome Trust Laboratory, Kilifi, Kilifi, 00000, Kenya
Work Preference
Work Type
Contract WorkLocation Preference
RemoteHybridTimeline
Clinical Laboratory Scientist
London School of Hygiene and Tropical Medicine
07.2018 - Current
Laboratory Consultant
RAMS Global Consulting Company
01.2016 - 12.2016
Laboratory Supervisor
KEMRI Wellcome Trust Program
01.1999 - 07.2016
Master of Science - Biomedical Sciences
University of Greenwich
Bachelor of Science - Medical Laboratory Science
Mount Kenya University
Higher National Diploma - Clinical Chemistry
Technical University of Kenya
Higher National Diploma - Immunology
Mombasa Technical University