Sheila Makena
Head of Special Projects at Pathologists Lancet Kenya- Claim this Profile
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English Native or bilingual proficiency
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Swahili Native or bilingual proficiency
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German Elementary proficiency
Topline Score
Bio
Credentials
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Fundamentals of Implementation Science
University of WashingtonFeb, 2023- Nov, 2024 -
Florence for IQVIA users
Florence HealthcareSep, 2021- Nov, 2024 -
Good Clinical Practice
The National Institute on Drug Abuse (NIDA)Jun, 2021- Nov, 2024 -
Biomedical Research
CITI ProgramJun, 2021- Nov, 2024
Experience
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Pathologists Lancet Kenya
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Kenya
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Medical and Diagnostic Laboratories
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1 - 100 Employee
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Head of Special Projects
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Nov 2022 - Present
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Kenya Medical Research Institute (KEMRI)
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Kenya
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Research Services
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700 & Above Employee
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Clinical Trials-Quality Control and Regulatory affairs
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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
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National Tuberculosis Reference Laboratory
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Philippines
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Hospitals and Health Care
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1 - 100 Employee
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Volunteer Research Assistant
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Mar 2021 - Jun 2021
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IQVIA
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United States
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Hospitals and Health Care
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700 & Above Employee
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Data Consultant
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Sep 2020 - Jan 2021
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Kenya Breweries Limited (KBL)
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Kenya
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Beverage Manufacturing
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200 - 300 Employee
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Quality Control Microbiologist
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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
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World Agroforestry
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Kenya
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Research Services
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400 - 500 Employee
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Student Research Assistant
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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
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Education
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University of Nairobi
Bachelors, Microbiology and Biotechnology