An accomplished clinical research professional with over 30 years experience gained across the NHS, CRO and Pharmaceutical industry. Now retired as Senior Specialist - Clinical Operations, Experimental Medicine at Lundbeck but have demonstrated responsibility for development and optimisation of global clinical pharmacology operations processes whilst ensuring appropriate internal adherence to GCP, SOPs, good scientific practices within the context of cultural diversity.Expert in the evaluation of global clinical sites for early phase studies. Expert in the oversight of clinical study set-up and execution with all that this entails. Expert in providing continuous, flexible, training and mentoring adapting to wide-ranging levels of experience and perspective to promote quality and efficiency. Previously managed global clinical pharmacology and special population studies including first-in-human and first-in-patient. Experience extends across Europe, China, Japan and the US. Fully conversant in global clinical site evaluation, vendor and CRA management, and ensuring efficient oversight activities. Therapeutic area experience includes depression, mood/sleep disorders, Schizophrenia, Parkinson’s and Alzheimer’s disease. Operational expertise extends beyond but includes on-road driving performance, PET ligand validation, MRI/PET/EEG, radio-labelled, Japanese-bridging studies, and so on. Phase II and III CRA experience gained with Amgen in the fields of Osteoarthritis and Rheumatoid Arthritis which followed a solid 10-year CRO role in Clinical Project Management managing approximately 90 Phase I studies for Covance CRU (Leeds) including first-in-man and complex pharmacodynamic studies. Successful collaborations established with academic experts from a wide range of disciplines and over 6 years experience of working in an NHS setting specialising in Dermatology clinical trial conduct and research (Acne, Psoriasis, and Eczema).
Listed skills include Clinical Pharmacology and Cro.