Clinical Trial Manager
“A dose reduction Immunobridging and safety study of two HPV vaccines in Tanzanian girls”. This study compared one dose of two different HPV vaccines to two doses and three doses of the same vaccine for the effect on immunological response up to 60 months post first vaccine dose. The study also investigated the effect of malaria during vaccination on the immune response. I was responsible for day-to-day oversight of trial activities, writing and submission of reports to ethics, regulatory and funding authorities, coordinating with the national immunisation programme, assuring ethical and regulatory approvals and study insurance was current, maintaining study documentation, writing SOPs, questionnaires, field manuals and other study documentation, monitoring and ensuring clinical, laboratory and data tasks were carried out in accordance with GCP, GCLP, GDPR, training personnel in their required role, procurement of study equipment and materials, dissemination of results to regional and national authorities and study participants, writing research papers and all other requirements of the study. I also adapted all documentation and trained the study team for working under conditions of infection control during the coronavirus epidemic.
