About Me
Leading end-to-end clinical trial operations with a strong focus on protocol execution, participant flow, and data quality across the South African regulatory landscape. Proven experience driving study start-up activities from feasibility through activation, including SAHPRA submissions, HREC approvals, and SANCTR registration, ensuring sites are inspection-ready and compliant with SA GCP requirements.
Strong operational ownership of site readiness and activation timelines, with hands-on coordination of contracts, essential documents, and system access to achieve rapid first-patient-in. Extensive experience working with eCOA, IRT/RTSM, and CTMS platforms, proactively resolving system issues to prevent visit delays and participant burden, while maintaining clean, audit-ready data.
Highly effective in sponsor and CRO collaboration, acting as the central operational link to manage timelines, close queries, mitigate risks, and maintain transparent communication across multi-site studies. Demonstrated capability in multi-site coordination within South Africa, aligning site teams, vendors, and monitors to ensure consistent execution and adherence to protocol.
Comprehensive management of investigational product lifecycle, including receipt, storage, dispensing, accountability, reconciliation, and return, with strong oversight of participant adherence and protocol compliance in line with ICH-GCP and local regulations. Experienced in identifying compliance risks early and implementing corrective actions through retraining, documentation, and process optimization.
Experienced in overseeing and training multi-disciplinary site teams, including coordinators, pharmacists, and investigators, fostering a culture of accountability, precision, and operational excellence. Known for maintaining high-quality source documentation, timely query resolution, and readiness for audits and inspections.
