Yomi O. Taylor
Katy,TX
Summary
Results-driven Clinical Trial Leader with extensive experience in end-to-end trial execution, demonstrating expertise in CRO and vendor oversight. Proven ability to lead cross-functional teams to optimize site feasibility and drive patient recruitment while ensuring effective collaboration with stakeholders. Strong background in risk management and CAPA implementation, maintaining inspection readiness and compliance with ICH-GCP and global regulatory standards. Proficient in budget management, contract negotiations, and vendor selection, consistently delivering trials on time and within budget while ensuring data integrity and operational excellence.
Overview
15
15
years of professional experience
Work History
Senior Clinical Trial Manager
ICON Plc
07.2023 - Current
- Lead, guide, and oversee CROs and vendors, ensuring they meet contractual obligations, performance metrics, and deliverables, while maintaining strict compliance with quality standards.
- Maintain a robust Trial Master File (TMF), lead site monitoring and oversight visits, and ensure constant audit/inspection preparedness, collaborating closely with Quality teams to uphold excellence in clinical trial execution.
- Oversee investigator site feasibility, selection, and engagement, ensuring a positive site experience while optimizing patient recruitment and retention through strategic initiatives.
- Identify trial risks, develop mitigation strategies, oversee corrective and preventative actions (CAPAs), and escalate potential cross-study, franchise, or regulatory impacts to senior leadership as needed.
- Ensure high-quality data capture, timely adverse event (AE/SAE) reporting, and adherence to global regulatory requirements, proactively addressing protocol deviations, and ensuring inspection readiness.
- Establish and lead the cross-functional Clinical Trial Team (CTT) in collaboration with the Lead Trial Physician, ensuring seamless coordination across all functions.
- Drive vendor selection, contract negotiations, and budget management, ensuring alignment with protocol scope, financial targets, and reconciliation processes, while maintaining fiscal accountability.
- Proactively manage and track study progress, key deliverables, and milestones, ensuring successful trial completion within scope, budget, and timelines.
- Oversee the configuration, implementation, and compliance of vendor systems, and study processes, ensuring alignment with protocol specifications, regulatory expectations, and data integrity standards.
- Oversee the end-to-end execution of clinical trials, ensuring adherence to protocol requirements, OGSM frameworks, ICH-GCP standards, and global regulatory guidelines, while fostering transparent communication with internal teams and external partners.
Senior Clinical Trial Manager
Amgen
07.2021 - 06.2023
- Directed a portfolio of Phase II oncology trials, overseeing trial design, site feasibility assessments, and patient recruitment strategies.
- Negotiated contracts with CROs, achieving cost savings of $500K annually, while maintaining high-quality deliverables.
- Conducted regular audits and inspections, ensuring zero critical findings during FDA audits.
- Spearheaded the development of risk mitigation plans, reducing protocol deviations by 30%.
- Streamlined site initiation processes, cutting site activation timelines by 25%.
- Authored comprehensive clinical study reports (CSRs), and supported regulatory submissions.
- Organized cross-functional workshops to align stakeholders on trial objectives and timelines.
- Trained new CRAs on monitoring techniques and regulatory documentation best practices.
- Successfully led a global regulatory submission, contributing to the FDA approval of an investigational drug.
- Reduced protocol deviations by 40% through the implementation of a targeted investigator training program.
Clinical Trial Manager
Proxima
03.2017 - 06.2021
- Managed Phase I-III clinical trials in neurology, coordinating activities across 30+ investigative sites
- Developed and executed risk mitigation plans, reducing protocol deviations by 40%
- Streamlined site initiation processes, cutting site activation timelines by 25%
- Authored comprehensive clinical study reports (CSRs) and supported regulatory submissions
- Conducted on-site monitoring visits to ensure compliance with GCP guidelines and protocol requirements
- Identified and resolved critical issues during site audits, improving overall site performance by 15%
- Implemented a centralized monitoring approach, decreasing site visit frequency by 25% while maintaining compliance
- Spearheaded an initiative that reduced trial data entry errors by 35%, improving overall data integrity
Senior Clinical Research Associate
Medpace
08.2014 - 02.2017
- Conducted on-site monitoring visits, ensuring compliance with GCP guidelines and protocol requirements
- Identified and resolved critical issues during site audits, improving overall site performance by 15%
- Trained new CRAs on monitoring techniques and regulatory documentation best practices
- Coordinated with investigative sites to resolve data discrepancies and ensure timely submission of required reports
- Maintained trial documentation and ensured readiness for regulatory inspections
- Led a site remediation program that turned a non-compliant site into a top-performing center
- Developed a CRA mentorship program that improved onboarding efficiency by 50%
Clinical Research Associate
Medpace
05.2012 - 07.2014
- Performed source document verification and data entry with 99% accuracy, ensuring data integrity and compliance
- Supported senior managers in preparing for regulatory inspections and audits, maintaining audit readiness
- Conducted regular communication with investigative sites to resolve queries and ensure protocol adherence
- Conducted over 100 monitoring visits across multiple therapeutic areas, ensuring site compliance
- Reduced data queries by 40% by introducing site training on proper data documentation
Clinical Study Coordinator
Baylor College of Medicine
01.2010 - 04.2012
- Coordinated participant recruitment and retention efforts, achieving enrollment targets ahead of schedule
- Maintained trial documentation and ensured timely submission of required reports to regulatory bodies
- Conducted site initiation visits and provided training to new site staff on protocol procedures
- Increased participant retention by 20% through enhanced patient follow-up strategies
- Developed an investigator training manual that streamlined onboarding for new clinical sites
Education
Masters in Transport Planning & Management -
University of Lagos
NGBachelor of Science - Biology
University of Lagos
NGSkills
- Regulatory Compliance
- Data Analytics & Reporting
- Mentoring team members
- Risk Mitigation & Management
- Stakeholder Engagement
- Strategic planning
- Conflict resolution
- Effective Communication
- Problem-solving aptitude
- Regulatory Affairs
- Global Trials Management
- Project Management
- Vendor management
- Clinical operations
- Cross-functional collaboration
Therapeutic Areas
- Oncology: Hematology, Lung Cancer, Breast cancer, Prostate cancer, Leukemia
- Rare Diseases: Cystic Fibrosis, DMD
- Infectious Diseases: HIV/AIDS, Hepatitis A & B, COVID-19, Tuberculosis
- Medical Devices: Pacemakers, Endoscopes, Ventilators
Timeline
Senior Clinical Trial Manager
ICON Plc
07.2023 - Current
Senior Clinical Trial Manager
Amgen
07.2021 - 06.2023
Clinical Trial Manager
Proxima
03.2017 - 06.2021
Senior Clinical Research Associate
Medpace
08.2014 - 02.2017
Clinical Research Associate
Medpace
05.2012 - 07.2014
Clinical Study Coordinator
Baylor College of Medicine
01.2010 - 04.2012
Masters in Transport Planning & Management -
University of Lagos
Bachelor of Science - Biology
University of Lagos
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