Sheila Makena

Head of Special Projects at Pathologists Lancet Kenya
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Contact Information
us****@****om
(386) 825-5501
Location
Nairobi County, Kenya, KE
Languages
  • English Native or bilingual proficiency
  • Swahili Native or bilingual proficiency
  • German Elementary proficiency

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Credentials

  • Fundamentals of Implementation Science
    University of Washington
    Feb, 2023
    - Nov, 2024
  • Florence for IQVIA users
    Florence Healthcare
    Sep, 2021
    - Nov, 2024
  • Good Clinical Practice
    The National Institute on Drug Abuse (NIDA)
    Jun, 2021
    - Nov, 2024
  • Biomedical Research
    CITI Program
    Jun, 2021
    - Nov, 2024

Experience

    • Kenya
    • Medical and Diagnostic Laboratories
    • 1 - 100 Employee
    • Head of Special Projects
      • Nov 2022 - Present

    • Kenya
    • Research Services
    • 700 & Above Employee
    • Clinical Trials-Quality Control and Regulatory affairs
      • Jun 2021 - Nov 2022

      • Provide support in quality and compliance of clinical trials with respect to Standard Operating Procedures, Good Clinical Practices, applicable regulatory requirements and ICH standards. • Ensuring clinical research personnel receive adequate SOP training required by the principles of the International Conference on Harmonization (ICH) and Guideline for Good Clinical Practice. • Ensuring timely notification of safety reports and protocol deviations to relevant authorities. ∙ Prepare and submit essential study documents from center review committee to IRB and regulatory authority. • Participate in audit preparation, hosting, and post-audit activities to promote the successful outcome of the audit. • Prepare and submit protocol amendments as required for IRB review. • Oversee and maintain all regulatory documents as assigned and provide availability as required for review, monitor requests and audits Show less

    • Philippines
    • Hospitals and Health Care
    • 1 - 100 Employee
    • Volunteer Research Assistant
      • Mar 2021 - Jun 2021

    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Data Consultant
      • Sep 2020 - Jan 2021

    • Kenya
    • Beverage Manufacturing
    • 200 - 300 Employee
    • Quality Control Microbiologist
      • Apr 2019 - Jun 2019

      Worked in the microbiology lab which involved work in: • Quality assurance of the beer products • Microbiological assessment of products at every stage of production- raw materials, brewing, filtering and packaging • Management of the yeast plant • Hygiene assessment and management of the brewery- Microbiological and chemical testing of water used all around the plant and sanitation checks on the equipment • Book keeping and data management using data management software Worked in the microbiology lab which involved work in: • Quality assurance of the beer products • Microbiological assessment of products at every stage of production- raw materials, brewing, filtering and packaging • Management of the yeast plant • Hygiene assessment and management of the brewery- Microbiological and chemical testing of water used all around the plant and sanitation checks on the equipment • Book keeping and data management using data management software

    • Kenya
    • Research Services
    • 400 - 500 Employee
    • Student Research Assistant
      • Aug 2017 - Sep 2017

      Worked in the molecular genetics lab alongside other geneticists. Involved in lab work including: • Extraction of DNA and preparation of reagents used in the lab. • Collection of samples of different plant species in the field. • Extraction of DNA from collected species • Quantification and qualitisation of extracted DNA • Preparation of reagents used in the laboratory Worked in the molecular genetics lab alongside other geneticists. Involved in lab work including: • Extraction of DNA and preparation of reagents used in the lab. • Collection of samples of different plant species in the field. • Extraction of DNA from collected species • Quantification and qualitisation of extracted DNA • Preparation of reagents used in the laboratory

Education

  • University of Nairobi
    Bachelors, Microbiology and Biotechnology

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