Clinical Operations Leader | Global Study Manager | Early-Phase Drug Development (Phase 1-4)
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Clinical operations leader with 9+ years across Phase 1–4 clinical development, with foundation and significant delivery in early-phase drug development. Experienced in leading global study teams end to end with direct accountability for milestones, timelines and budgets. Early-phase expertise built at a busy London clinical-pharmacology CRO running Phase 1–2 operations across oncology, cardiovascular, pain, vaccine and CNS programmes.
Completed two full end-to-end study lifecycles in oncology, recruited 1,200 participants across a $4M portfolio, and delivered on time and within scope. Proficient in risk-based monitoring, ICH/GCP adherence, vendor performance management, and cross-functional collaboration. Proven track record of team leadership, coaching, process improvement and adoption of emerging clinical technologies.
Clinical Operations Lead - London clinical-pharmacology CRO - London, United Kingdom
Led Phase 1–2 operations across oncology, cardiovascular, pain, vaccine and CNS programmes. Authored protocols, ICFs, CRFs and CSRs and led CTA/EMA submissions.
UK Single-Point-of-Contact Lead - Phase 1/1b Oncology Trials - UK Pharma / Biotech - United Kingdom
Completed two full end-to-end study lifecycles in Phase 1 and Phase 1/2 oncology trials.
Clinical Operations / Study Management - Roche and other organisations - Multiple locations (UK, Germany, Spain, US, Japan, China)
Delivered studies across multiple geographies. Designed and oversaw risk-based monitoring, maintained ICH/GCP adherence and inspection readiness, and provided strategic direction to CROs and functional vendors including IQVIA, ICON, Syneos, LabCorp, Cognizant, and Median. Partnered across Regulatory Affairs, R&D, Biostatistics, Data Management and Medical Affairs.
