F J

Clinical Study Director with over 10 years' experience across clinical trials, diagnostics, clinical supply, and regulated laboratory environments. Extensive background delivering early to late-phase studies, managing global clinical supply chains, and ensuring compliance with GCP, MHRA, FDA, and GxP standards. HCPC-registered biomedical scientist combining scientific rigour, operational leadership, and strong SQL-driven data analytics to deliver high-quality clinical programmes and operational excellence.

Clinical Study Director at Norbrook (2024-12 – Present)

• Lead end-to-end execution of clinical trials, ensuring alignment with regulatory requirements, corporate strategy and scientific integrity.
• Coordinate multidisciplinary teams across regulatory, medical, data management, manufacturing, and quality functions.
• Oversee protocol development, review, and finalisation to ensure scientific validity and regulatory compliance.
• Select, onboard, and manage CROs and external vendors, monitoring performance and contractual compliance.
• Maintain inspection readiness through robust documentation and strict adherence to GCP, MHRA, and FDA guidelines.
• Utilise data-driven oversight to monitor trial progress, patient safety, and endpoint trends, driving continuous improvement.

Clinical Supply Associate at Almac (2024-05 – 2024-12)

• Managed multiple global clinical supply projects supporting early- and late-phase clinical trials.
• Applied advanced SQL for forecasting, inventory management, and supply chain optimisation, reducing risk and waste.
• Conducted proactive risk assessments and implemented mitigation strategies to ensure uninterrupted drug supply.
• Served as primary client contact, building strong relationships through effective communication and problem-solving.
• Oversaw IRT system setup, maintenance, and data updates to support randomisation and medication management.
• Monitored project budgets, scope changes, and timelines to balance operational delivery with financial control.

Specialist Biomedical Scientist at NHS (2019-05 – 2024-05)

• Optimised laboratory operations through real-time systems integration, improving workflow efficiency and data accuracy.
• Led and contributed to research initiatives and diagnostic test innovations in high-throughput clinical environments.
• Operated advanced diagnostic equipment including Roche analysers, delivering high-quality analytical results.
• Provided expert troubleshooting across complex laboratory and IT systems to maintain uninterrupted service delivery.
• Enforced rigorous quality control and assurance procedures to ensure accuracy, reliability, and regulatory compliance.
• Communicated complex technical and clinical data clearly across multidisciplinary healthcare teams.

Biomedical Scientist at Randox (2015-05 – 2019-05)

• Delivered compliant laboratory operations through strict adherence to GMP and GCP standards.
• Applied SQL and data analysis to support clinical trial workflows, reporting, and documentation accuracy.
• Implemented quality control measures to enhance laboratory safety and operational performance.
• Provided technical guidance to clients across clinical trial lifecycles and diagnostic platforms.
• Built strong client relationships, contributing to increased uptake of additional products and services.
• Supported development and validation activities for diagnostic assays within regulated environments.

BSc (Hons) in Biomedical Science – Ulster University