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Krystal Ogwuru

@krystalogwuru

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I deliver global Phase I–III clinical trials with audit-ready quality, budget control, and operational leadership.

United States

Message

I currently lead Pfizer-sponsored global Phase I–III trials at ICON Strategic Solutions across more than 15 countries, accountable for timelines, budgets, data quality, and ICH-GCP compliance from feasibility through database lock.

I've delivered oncology, rare disease, vaccine, cardiovascular, infectious disease, immunology, and respiratory studies, while building risk-adjusted monitoring strategies, leading study start-up, and maintaining zero critical findings across multiple FDA, EMA, and local-authority inspections.

I line-manage global CRA, aCRA, and CTA teams and partner with CROs, vendors, sites, and cross-functional stakeholders to resolve risk early. My MBA and prior financial-analysis experience strengthen my budgeting, forecasting, reconciliation, and vendor-negotiation work.

Experience

Work history, roles, and key accomplishments

Current

Global Study Operations Manager

Current

ICON Strategic Solutions

Feb 2024 - Present (2 years 7 months)

Drive end-to-end delivery of global Phase I-III clinical trials across multiple therapeutic areas, holding accountability for on-time, on-budget execution in compliance with ICH-GCP. Manage trials in over 15 countries, lead monitoring strategy, and line-manage a global CRA team.

Clinical Trial Management ICH GCP Risk Based Quality Management vendor negotiation Budget Forecasting Study Start Up Deviation Management Audit Readiness CRA Line Management Strategic Monitoring ETMF Veeva Medidata EDC Oracle Clinical One Spotfire Impala

Clinical Trial Manager

Syneos Health

Jul 2019 - Feb 2024 (4 years 7 months)

Provided leadership and oversight to CRAs across end-to-end protocol execution, driving compliance, data quality, and timely issue resolution. Oversaw CRO and vendor performance, managed study budgets, and ensured inspection readiness.

Clinical Trial Management CRO Oversight Vendor Management Risk Management data review ETMF Budget Management Site management Protocol Development ICH GCP

Senior Clinical Research Associate

Cromsource

May 2017 - Jul 2019 (2 years 2 months)

Conducted full monitoring visit cycles across multiple concurrent studies and sites, ensuring compliance with protocol and regulatory requirements. Managed site activation milestones and provided investigator site training.

Clinical Monitoring Site management ICH GCP Regulatory Compliance EDC Remote Monitoring Investigator Training Quality Assurance

Clinical Research Associate

Cromsource

Jan 2015 - May 2017 (2 years 4 months)

Performed pre-study, initiation, interim monitoring, and close-out visits across assigned sites. Escalated site performance issues and supported maintenance of clinical project documentation.

Clinical Monitoring Site visits Regulatory Submissions Adverse Event Reporting Investigational Product Management Documentation

Clinical Research Coordinator

So Cal Clinical Research

Jan 2013 - Jan 2015 (2 years)

Acted as primary site point of contact for assigned studies, coordinating subject visits and liaising with sponsor monitors, investigators, and site pharmacists. Tracked patient enrolment and maintained source documentation.

Patient Coordination Data Entry Regulatory Binder Adverse Event Reporting Training CRF Completion Guidelines

Senior Financial Analyst

Honeywell International

Jul 2009 - Jan 2013 (3 years 6 months)

Managed pricing, funding allocation, and financial reporting for a federal contract to NASA, applying work breakdown structures to control project budgets. Presented monthly budget-to-actual and variance analysis reports.

Financial Analysis Budgeting Forecasting Variance Analysis Federal Contracting SAP Microsoft Office