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collymo.

Clinical research journey

Five years of trial data, regulation and quality.

From data clerk to Data Coordinator: data management and regulatory work on 13 clinical studies, Phase 1 to 4, at Butere Clinical Research Centre and Victoria Biomedical Research Institute.

Studies
13
Phases
1–4
Since
2021

Timeline

My roles

  1. Feb 2025 – present

    Data Coordinator

    Victoria Biomedical Research Institute (VIBRI)

    • Oversees data collection quality control, data entry, query resolution and statistical analysis, with performance reports
    • Generates statistical follow-up and monitoring reports
    • Designs and maintains data collection forms and study-specific source documents
    • Manages database backups and study filing systems
    • Documents data cleaning, standardisation and analysis procedures
    • Builds participant visit schedules and planners
    • Site visits to troubleshoot data issues

  2. Feb 2024 – Feb 2025

    Regulatory Officer

    Butere Clinical Research Centre (BCRC)

    • Regulatory documentation and submissions under GCP and applicable guidelines
    • Liaison with ethics committees, sponsors and investigators for study approvals
    • Timelines, communication and documentation for submissions and audit preparation

  3. Sep 2021 – Feb 2025

    Data Manager

    Butere Clinical Research Centre (BCRC)

    • Data clerk and data manager across Phase 1 to 4 clinical trials and validation studies
    • Data entry, validation and digitisation for clinical research
    • Document control, organisation and archiving

  4. Jul 2021

    Good Clinical Practice certification

    CITI Program

Studies

Studies by type and phase

Data clerk and data manager on the studies below. They are summarised by therapeutic area and phase; protocol identifiers and sponsors are not shown.

Vaccine trials

7 studies
  • Phase 2bTuberculosis vaccine efficacy, safety and immunogenicityAdolescents and adults aged 14–45
  • Phase 3Tuberculosis vaccine prophylactic efficacy, safety and immunogenicityAdolescents and adults
  • Phase 2/3Bivalent typhoid and paratyphoid A conjugate vaccineInfants aged 9–12 months
  • Phase 3Respiratory syncytial virus (RSV) vaccineInfants and toddlers
  • Phase 3Measles, mumps and rubella (MMR) vaccine non-inferiorityChildren aged 9–11 months
  • Phase 3Adjuvanted recombinant protein COVID-19 vaccinesAdults 18+
  • Phase not statedInfant combination vaccine on the national immunisation scheduleInfants

Sickle cell disease therapeutics

4 studies
  • Phase 1Single and multiple ascending dose safety and pharmacokineticsHealthy volunteers and people with sickle cell disease
  • Phase 2/3Efficacy and safety of an investigational therapyPeople with sickle cell disease
  • Phase 3Reducing vaso-occlusive crisesAdolescents and adults
  • Phase 4Treatment of leg ulcersPeople with sickle cell disease

Infectious disease: treatment

1 study
  • Phase not statedClearance of high-risk human papillomavirus (HPV)Randomised, placebo-controlled

Diagnostics validation

1 study
  • Non-interventionalClinical validation of a scanner for detecting HIV, tuberculosis and malariaValidation study

Want the full detail?

My CV is available on request.

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