Cape Town, Western Cape, South Africa
I am an outcome-driven Clinical Project Manager with three years of experience in early-phase clinical trials and client-facing roles, delivering Phase 1–3 trials across multiple therapeutic areas. With a strong foundation at the CRO level, I have successfully led and supported cross-functional teams in designing, scoping, budgeting, and executing complex projects—from trial initiation to reporting. I excel in strategic planning, regulatory compliance (FDA, EMA, ICH-GCP, SA GCP), quality and risk management, and stakeholder engagement. My adaptability and substantial experience in difficult-to-treat diseases, such as TB, allow me to acquire expertise rapidly in new therapeutic areas. Core Competencies: ✔ Project Management: Agile & Waterfall methodologies for end-to-end trial execution. ✔ Regulatory Compliance: Ensuring adherence to global regulatory standards. ✔ Risk & Quality Management: Proactively identifying and mitigating risks. ✔ Stakeholder & Client Engagement: Effective collaboration across sponsors, vendors, and internal teams. ✔ Data-Driven Decision Making: Leveraging analytics for project success. ✔ Budget & Resource Management: Overseeing contracts, financials, and resource allocation. ✔ Clinical Supply Chain: Managing global logistics, imports/exports, and trial supply coordination. ✔ Inspection Readiness & TMF Management: Implementing electronic systems for streamlined oversight. I don’t just manage projects—I drive them to success. Whether in a CRO or Pharma environment, I bring strategic oversight, problem-solving, and a commitment to advancing clinical development and patient outcomes.
Project delivery was my primary focus, and my ability to align with the sponsor’s strategic objectives, understand cross-functional team dynamics, and leverage subject matter expertise enhanced efficiency. Clear, effective communication keeps every stakeholder engaged and supported throughout the process. ✔ Led cross-functional teams in planning and executing clinical projects, ensuring on-time and on-budget delivery. ✔ Developed and implemented risk mitigation strategies to proactively address potential project disruptions. ✔ Aligned project goals with industry standards by collaborating with regulatory affairs, quality assurance, and clinical operations. ✔ Provided real-time project updates to sponsors, leadership and key stakeholders, ensuring transparency and accountability. ✔ Served as the primary liaison between sponsors, CROs, and internal teams to drive project timelines and deliverables. ✔ Managed project budgets, ensuring the scope of work was covered appropriately. ✔ Maintained inspection-ready documentation and ensured TMF completeness through collaboration with functional teams. ✔ Optimized global logistics and supply chain operations for clinical trials, ensuring regulatory compliance and efficiency. Beyond execution, I implemented process improvements that eliminated project overruns, resolved under-scoped projects, and enhanced overall project organization. I successfully led the development of project plans, timelines, scope, and budgets, consistently meeting key performance indicators and strategic objectives. My Work Supported: ✔ Project Intake & Selection – Evaluating and selecting projects that align with strategic goals. ✔ Program & Portfolio Oversight – Managing multiple projects to ensure they deliver intended business outcomes. ✔ Benefits Management – Ensuring projects drive measurable value and align with broader organizational objectives. ✔ Resource Coordination – Allocating and optimizing resources for successful project execution.
I worked for a Chronic Medicine Distribution Company as Pre-Dispensing Manager responsible for Quality and Operations. I managed a department responsible for pre-packing medication, which would form part of a Patient Medicine Parcel. We supplied our Production team (for the Quality Assurance process) with specific pack sizes of medication from an extensive and dynamic database of 900+ stock items (70% of the Inventory) we managed monthly. Accurate forecasting of products/needs was one of my key competencies. Our internal QA process was essential and equated to a Manufacturer’s batch release system; hence I have Batch management and Release experience.
This was my Community Service year. I worked in the Production Department of the same Chronic Medicine Distribution Company as a Quality Assurance Pharmacist. I supervised a team of Post-Basic Assistants who checked and packed medication into Patient Medicine Parcels, according to a prescription processed by the Order Processing Department. We worked on a monthly scheduler and the Automated Dispensing team to supply over 500 000 patients within the Western Cape Chronic Dispensing Unit (CDU) system. I introduced and advocated for a Quality Management System that ensured errors carried forward to production are intercepted (through troubleshooting documents and official SOP creation). This grew into a function that now has a defined team and a Manager.
PhD Full time
Multiple Phase I skin blanching trials exploring the bioequivalence of corticosteroid creams