Open to opportunities

Valerie DAVIES SESAY

@valeriedaviessesay

Message

Senior clinical program leader with 20+ years delivering Phase II–III global trials.

France

Message

What I'm looking for

I’m looking to lead global Phase II–III clinical programs, strengthening portfolio-level operational governance, inspection-ready compliance, and budget discipline—while accelerating study start-up and mitigating operational risk with cross-functional, multi-vendor teams.

Senior Clinical Leader with 20+ years of international experience directing global Phase II–III programs across neurology, rare diseases, oncology, immunology, and endocrine disorders. I lead portfolio-level operational governance, global trial execution, budget management (€6M–€15M), and inspection-ready compliance—translating operational insights into strategic decisions that protect timelines, budgets, and data quality.

I’m known for accelerating study start-up, optimizing resource allocation, and mitigating operational risk across Europe, UK, and global regions. From leading 4+ concurrent programs across 25 countries to implementing risk-based monitoring and CAPA frameworks, I partner with executive stakeholders and cross-functional, multi-vendor teams to deliver complex studies efficiently. I also bring early-career CRA depth (2002–2012), mentoring teams and maintaining inspection-ready eTMFs.

Experience

Work history, roles, and key accomplishments

Current

Senior Global Clinical Lead

Current

ICON plc

Nov 2021 - Present (4 years 5 months)

Directed operational governance of 4+ concurrent Phase II–III programs across 25 countries and 80–150 investigative sites, managing clinical budgets of €6M–€15M through forecasting and variance analysis. Accelerated global site activation across four continents, reducing start-up cycle time by 5 weeks, and led CAPA/risk-based frameworks to maintain inspection-ready GCP compliance.

Clinical Trial Operations Budgeting & Forecasting Risk Based Monitoring CAPA GCP Compliance Stakeholder Management

Senior Clinical Project Manager

Clinipace Worldwide

Feb 2018 - Oct 2021 (3 years 8 months)

Led site performance strategy and vendor oversight for multi-country Phase II–III trials, improving enrollment, compliance, and data integrity. Managed study-level budgets and grant administration, and implemented KPI/performance frameworks with CRO partners to reduce site activation time and mitigate operational risk.

Site Performance KPI Tracking Grant Administration Compliance Management Data Integrity Risk Mitigation

International Clinical Project Manager

Worldwide Clinical Trials

Mar 2013 - Feb 2018 (4 years 11 months)

Managed multi-country Phase II/III cardiology and neurology programs, coordinating global teams for site selection, feasibility, regulatory submissions, and eTMF readiness. Implemented risk mitigation and operational governance to protect timelines and data quality while ensuring ongoing compliance.

Regulatory Submissions ETMF Risk Mitigation GCP Compliance Data Quality Management