Lesego Manthata
@lesegomanthata
I coordinate clinical trial start-up, regulatory submissions, TMF quality control, and site activation readiness.
South AfricaWhat I'm looking for
At Ubuntu Clinical Research, I coordinate study start-up and site activation, preparing and submitting regulatory documentation to Ethics Committees and SAHPRA while tracking approvals and timelines.
I maintain inspection-ready TMF and essential documents, identify documentation gaps, support CAPA activities, and work with investigators, CRAs, sponsors, and study teams to strengthen ICH-GCP and GDP compliance.
Experience
Work history, roles, and key accomplishments
Pharmacist assistant / Regulatory officer / SSC
Ubuntu Clinical Research
Jan 2024 - Present (2 years 8 months)
Conducts quality-focused review of regulatory and clinical trial documentation, leads study start-up and site activation activities, and manages regulatory submissions to Ethics Committees and SAHPRA. Maintains TMF documentation and supports audit readiness.
Store Manager
New Clicks Regional Office
Jun 2018 - Jan 2023 (4 years 7 months)
Managed operational performance, budgets, and KPIs in a high-volume environment, led teams, and maintained compliance with operational standards.
Facilitator, Beyonder diversity and inclusion
Clicks
Jun 2019 - Mar 2021 (1 year 9 months)
Facilitated structured training and development sessions, supported learner engagement, and coordinated programme delivery across teams.
Education
Degrees, certifications, and relevant coursework
University of South Africa
Diploma, Human Resource Management
2024 -
Pursuing a Diploma in Human Resource Management, ongoing since January 2024.
University of Cape Town
Certificate, Training and Developmental Management
2023 - 2023
Grade: Distinction
Completed a Certificate in Training and Developmental Management with distinction from January to June 2023.
Health Science Academy
Pharmacist Assistant Post Basic, Pharmacy
2019 - 2022
Completed a Pharmacist Assistant Post Basic qualification from June 2019 to March 2022.
Tech stack
Software and tools used professionally
Availability
Location
South AfricaAuthorized to work in
Salary expectations
Job categories
Skills
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