Clinical trial management
Jane Nabbuto
Clinical Trial Manager
Kampala
Summary
My research contributions have focussed on strengthening HIV prevention and infectious disease trials in sub-Saharan Africa, with an emphasis on delivering high-quality studies that produce reliable and actionable evidence. I have worked across laboratory operations, trial oversight, and research governance, translating complex protocols into studies that run smoothly and meet international standards.
Clinical research professional with strong focus on managing clinical trials and ensuring regulatory compliance. Skilled in project management, data analysis, and stakeholder engagement. Known for fostering team collaboration, adapting to changing needs, and delivering reliable results. Adept at navigating complex protocols and driving clinical studies to successful completion.
Overview
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1
Language
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Certification
21
21
years of professional experience
Work History
Clinical Trial Manager
Medical Research Council and London School of Hygiene and Tropical Medicine, Uganda
12.2022 - Current
- In my role as Clinical Trial Manager (Laboratory Operations), I oversee all laboratory activities supporting clinical trials, ensuring compliance with GCP, GCLP, and applicable regulatory and ethical requirements.
- I lead laboratory components of trial start-up and close-out, including laboratory readiness, sample handling, testing, and storage, validation of assays and processes, quality assurance, and maintenance of data integrity across multiple studies.
- I work closely with investigators, sponsors, and multidisciplinary teams to ensure protocols are implemented accurately and efficiently.
- I oversee laboratory staff, providing training and mentorship and addressing operational challenges.
- I also develop, review, and implement laboratory SOPs to standardize processes.
- Facilitated training sessions for new staff on clinical trial procedures, fostering a culture of continuous improvement and compliance.
- Collaborated with external stakeholders to streamline communication and enhance project outcomes across the clinical trial lifecycle.
- Utilized data management tools to analyze trial results, supporting strategic decision-making and evidence-based practices.
- Oversaw site selection and initiation processes, ensuring alignment with study objectives and participant safety.
- Fostered strong relationships with investigative sites, leading to increased collaboration and improved study outcomes.
- Spearheaded the selection of appropriate clinical sites by conducting thorough feasibility assessments based on predefined criteria.
- Reduced operational costs through effective budget management, negotiation with vendors, and careful allocation of resources.
- Managed cross-functional teams to ensure timely completion of clinical trial milestones and deliverables.
- Supported the preparation of clinical study reports by providing accurate data analysis and interpretation for inclusion in final documentation.
- Championed continuous improvement initiatives within the organization by sharing best practices and lessons learned from previous trials with colleagues and team members.
- Enhanced patient safety by meticulously monitoring clinical trial activities and promptly addressing any issues.
- Evaluated vendor performance regularly to ensure high-quality services were provided throughout the duration of the clinical trial. and
- Implemented quality assurance measures to monitor trial progress and mitigate risks, resulting in improved data integrity.
Sponsor Clinical Research Assoicate
DNDi
02.2022 - 12.2022
- Facilitated communication between stakeholders to streamline project coordination and enhance collaboration across departments.
- Implemented risk management strategies during trials, mitigating potential issues and ensuring adherence to safety protocols.
- Utilized data management systems to track study metrics, supporting informed decision-making and timely reporting.
- Contributed to the development of patient recruitment strategies, increasing enrollment rates and optimizing study timelines.
- Trained and mentored junior staff on best practices in clinical trial management, fostering professional growth and team effectiveness.
- Collaborated with cross-functional teams to develop clinical study protocols, improving study design and execution.
- Monitored clinical trial progress, identifying issues proactively to maintain timelines and ensure quality data collection.
Lead Clinical Research Associate
Medicines San Frontier/Epicenter Research Centre
08.2020 - 11.2022
- I coordinated clinical monitoring and site management, supervised study monitors, conducted site training, and collaborated with laboratory, data, and statistics teams to ensure data quality and regulatory compliance.
- I oversaw multicenter trials including yellow fever vaccine studies, ZEBOVAC, COVAC-2, pediatric HIV trials, TB treatment and diagnostic studies, and community TB interventions.
- Managed site selection and feasibility assessments, contributing to successful project initiation and resource allocation.
- Coordinated communication between stakeholders, facilitating timely issue resolution and maintaining project timelines.
- Conducted quality assurance reviews of monitoring reports, ensuring adherence to protocols and enhancing data integrity.
- Participated in strategic planning sessions, providing insights that guided study design and operational strategies.
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Enhanced data quality by closely monitoring study progress and ensuring accurate data collection.
- Supported the successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of the study process.
- Led the design and implementation of clinical trial protocols, ensuring regulatory compliance and operational efficiency.
- Mentored junior staff on best practices in clinical monitoring, enhancing team productivity and trial outcomes.
- Developed comprehensive training materials for new team members, improving onboarding efficiency and knowledge retention.
- Collaborated with cross-functional teams to streamline data collection processes, increasing the accuracy of trial results.
- Led the development and implementation of study protocols to ensure compliance with regulatory standards.
- Managed cross-functional teams to coordinate clinical trials, enhancing operational efficiency and data integrity.
- Oversaw site selection and initiation processes, resulting in improved patient recruitment and retention strategies.
- Trained and mentored junior staff on clinical research methodologies, fostering professional growth and team effectiveness.
- Conducted comprehensive data analysis and reporting, contributing to informed decision-making and study outcomes.
- Collaborated with external stakeholders to optimize study designs, enhancing overall project timelines and deliverables.
- Facilitated communication between investigators and regulatory bodies, ensuring alignment and clarity throughout the research process.
Study Coordinator (consultant)
Makerere University School of Public Health (AGYW Project)
11.2019 - 08.2020
- I managed large multidisciplinary teams, coordinated field and clinic operations, oversaw budgets and procurement, ensured timely donor reporting, and supported dissemination of findings, integrating clinical, laboratory, and data components for smooth delivery.
- Monitored data integrity and compliance during studies, contributing to successful audit outcomes and research validity.
- Implemented process improvements for participant tracking systems, resulting in enhanced data accuracy and retrieval speed.
- Developed training materials for new staff, fostering a culture of knowledge sharing and continuous learning.
- Collaborated on cross-functional teams to address challenges in study implementation, improving project timelines and outcomes.
- Streamlined communication between participants and research team, fostering effective collaboration and data collection.
- Supported participant retention efforts by designing engaging materials that highlighted the benefits of continued involvement in the study.
- Enhanced interdisciplinary collaboration among researchers by organizing regular team meetings and progress updates.
- Promoted a culture of continuous improvement within the research team through constructive feedback on study processes and outcomes.
- Optimized resource allocation for the research project, effectively managing budgets and personnel requirements.
- Coordinated multiple research projects, ensuring adherence to timelines and compliance with protocols.
- Facilitated recruitment and onboarding of study participants, enhancing enrollment efficiency and engagement.
- Managed data collection and ensured accuracy, contributing to reliable research outcomes and findings.
- Developed and implemented training materials for staff, improving operational effectiveness and knowledge retention.
- Oversaw budget tracking and resource allocation, optimizing project expenditures and financial reporting.
- Collaborated with cross-functional teams to streamline processes, fostering a culture of continuous improvement.
- Provided mentorship to junior staff, enhancing team capabilities and promoting professional development.
- Conducted regular audits of study protocols, maintaining compliance with ethical standards and regulatory requirements.
Training and Capacity Building Coordinator
Uganda Virus Research Institute, HIV Reference Laboratory
10.2013 - 03.2019
- I led PEPFAR-supported initiatives to strengthen laboratory, surveillance, and public health systems through structured planning, training delivery, and performance reporting.
- Collaborated with cross-functional teams to streamline processes and enhance training resources.
- Conducted needs assessments to identify skill gaps and inform targeted training strategies.
- Led efforts to document training processes, contributing to improved resource management and accessibility.
- Developed and implemented training programs to enhance staff knowledge and compliance with HIV protocols.
- Conducted capacity assessments to identify training needs and ensure effective resource allocation.
- Facilitated workshops and seminars to promote best practices in HIV research and data management.
- Collaborated with multidisciplinary teams to design and improve training curricula for laboratory staff.
- Evaluated training effectiveness by collecting feedback and adjusting materials to meet participant needs.
- Mentored junior staff, fostering a collaborative learning environment to enhance overall team performance.
- Analyzed training data to inform decision-making and drive improvements in program delivery.
- Established strong partnerships with stakeholders to support training initiatives and capacity building efforts.
- Spearheaded change management initiatives throughout the organization, fostering adaptation to new processes or systems introduced.
- Coordinated cross-functional teams to develop and implement capacity building initiatives, streamlining processes and improving overall performance.
- Established a mentorship program to foster skill development and knowledge sharing among team members.
- Evaluated program effectiveness by tracking progress against key performance indicators and adjusting strategies as needed.
- Bolstered employee engagement levels by actively soliciting feedback from staff members regarding their professional development needs.
- Monitored the impact of implemented strategies on overall organizational performance using various evaluation methodologies.
- Cultivated strong relationships with external partners such as consultants or subject matter experts enlisted to assist in capacity-building efforts.
- Ensured consistency in approach across all departments by developing standardized protocols for implementing capacity-building interventions.
- Enhanced organizational capacity by conducting needs assessments and identifying areas for growth.
- Promoted a culture of continuous learning within the organization, encouraging open communication and feedback among team members.
Senior Science Officer (Research Compliance)
Uganda National Council for Science and Technology
02.2005 - 09.2013
- I supported ethical review, regulatory compliance, and capacity building.
- I was a member of the MOH Technical Working Group for the National HIV Certification Framework (2016).
- Led the development and implementation of innovative research methodologies, enhancing project outcomes.
- Collaborated with cross-functional teams to advance scientific initiatives, driving impactful research findings.
- Mentored junior scientists, fostering professional growth and improving team productivity and cohesion.
- Managed multiple research projects simultaneously, ensuring adherence to timelines and quality standards.ganda
- Conducted comprehensive data analysis, providing critical insights for strategic decision-making and policy recommendations.
- Facilitated stakeholder engagement sessions to articulate research findings and gather diverse perspectives.
- Evaluated and optimized laboratory protocols, resulting in increased efficiency and reduced resource consumption.
- Developed training materials and workshops, enhancing team knowledge and ensuring compliance with best practices.
- Established effective relationships with key stakeholders both internally and externally for increased collaboration opportunities.
- Enhanced communication between team members by organizing regular meetings and fostering open dialogue.
- Improved department efficiency by streamlining and implementing policies and processes.
- Coordinated cross-functional teams to address complex issues, leading to more efficient problem-solving processes.
- Led the development and implementation of national science policies, enhancing research collaboration.
- Conducted comprehensive reviews of scientific proposals, ensuring alignment with national research priorities.
- Mentored junior scientists, fostering professional growth and reinforcing best practices in research methodologies.
- Coordinated multi-disciplinary research teams, streamlining project workflows and improving overall project efficiency.
- Facilitated stakeholder workshops, effectively communicating scientific advancements to enhance public understanding.
- Drafted policy briefs and reports, synthesizing complex scientific information for diverse audiences.
- Promoted science education programs, increasing community engagement through outreach initiatives and partnerships.
Education
Master of Science - Population And Reproductive Health
Makerere University
Kampala, Uganda 04.2001 -
Fellowship - Continuous Quality Improvement
Makerere University School of Public Health
01-2013
Post graduate Diploma - Health Research Ethics
University of Stellenbosch
Cape Town, South Africa01-2012
Bachelor - Biomedical Laboratory Technology
Makerere University
11-2003
Skills
Clinical trial management
GCP compliance
GCLP standards
Laboratory operations
Quality assurance
Data integrity
Protocol implementation
Staff training
Site selection
Feasibility assessments
Budget management
SOP development
Regulatory compliance
Clinical monitoring
Stakeholder communication
Continuous improvement
Project management
Accomplishments
Iam a biomedical scientist and clinical research professional with over five years of experience managing complex international clinical trials and health systems strengthening projects across Africa. One of my most significant professional achievements has been leading laboratory operations for large multicentre clinical trials, including the IMPALA and PREPVACC studies, ensuring compliance with GCP, GCLP, and sponsor requirements while supporting recruitment and follow-up of thousands of study participants across multiple sites.
As Lead Clinical Research Associate for MSF/Epicentre and Sponsor CRA for DNDi, I successfully coordinated monitoring activities across several African countries, contributing to high-quality data collection, protocol compliance, and successful regulatory inspections. In my current role as Clinical Trial Manager at MRC/UVRI & LSHTM Uganda, I oversee laboratory operations, cross-functional teams, budgets, and study implementation activities for complex infectious disease and vaccine trials.
Academically, I have contributed to multiple peer-reviewed research projects and scientific presentations in infectious diseases, HIV, and vaccine research. I have also completed professional certifications in Clinical Research and Clinical Trial Monitoring and was competitively selected for advanced training in Clinical Operations and Implementation Science. Throughout my career, I have mentored research staff, strengthened laboratory and trial management systems, and supported the successful delivery of studies that inform policy and improve public health outcomes in resource-limited settings.
Affiliations
HIV interventions Department, Clinical Trial Plat form, Medical Research Council and London School of Hygiene and Tropical Medicine, Uganda
Additional Information
Certified clinical research professional with extensive experience in multicountry clinical trials, laboratory operations, regulatory compliance, and team leadership. Skilled in stakeholder engagement, capacity building, and managing complex research projects that contribute to evidence-based public health interventions
Certification
Clinical Tril Monitoring, ACRP, 2021
Interests
Clinical Tril Monitoring
Research capacity strenthening
Mentorship and professional development
Scientific writing
Timeline
Clinical Trial Manager
Medical Research Council and London School of Hygiene and Tropical Medicine, Uganda
12.2022 - Current
Sponsor Clinical Research Assoicate
DNDi
02.2022 - 12.2022
Lead Clinical Research Associate
Medicines San Frontier/Epicenter Research Centre
08.2020 - 11.2022
Study Coordinator (consultant)
Makerere University School of Public Health (AGYW Project)
11.2019 - 08.2020
Training and Capacity Building Coordinator
Uganda Virus Research Institute, HIV Reference Laboratory
10.2013 - 03.2019
Senior Science Officer (Research Compliance)
Uganda National Council for Science and Technology
02.2005 - 09.2013
Master of Science - Population And Reproductive Health
Makerere University
04.2001 -
Post graduate Diploma - Health Research Ethics
University of Stellenbosch
Fellowship - Continuous Quality Improvement
Makerere University School of Public Health
Bachelor - Biomedical Laboratory Technology
Makerere University
Conference Presentations
- Laboratory operations, material transfer agreements (MTAs), shipments, and sample management across trial sites, IMPALA Trial Investigators Meeting, Nairobi, Kenya, Oral presentation, 2024-01-01
- Sample management systems and laboratory coordination in a multicentre PrEP trial, IMPALA Trial Investigators Meeting, Entebbe, Uganda, Oral presentation, 2023-01-01
- MobileMen Trial Investigators Meeting, MobileMen Trial Investigators Meeting, Virtual, Participation, 2024-01-01
Closing Statements
Senior Research Manager, Jane Nabbuto