Elizabeth Alabi
Dallas,TX
Summary
Clinical Research and Project Management professional with 7+ years of experience supporting and coordinating Phase I-III clinical trials across multiple therapeutic areas. Skilled in crossfunctional collaboration, site management, regulatory compliance, risk-based monitoring, and project coordination to ensure efficient study execution and patient safety. Proven ability to manage timelines, support audit-ready documentation, reduce protocol deviations, and support successful trial delivery in fast-paced clinical environments.
Overview
8
8
years of professional experience
Work History
Project Manager
BrightSpring Health Services
10.2022 - Current
- Managed multiple Phase I-III cross-functional trial projects, ensuring regulatory compliance and high data accuracy.
- Independently managed monitoring activities across multiple clinical trial sites, ensuring continuous inspection readiness.
- Produced weekly status reports highlighting milestones, open risks, blockers, and dependency impacts.
- Reviewed sprint actuals versus estimates and analyzed Rally and Jira data to monitor velocity and spend projections.
- Managed investigational product accountability with zero compliance findings.
- Oversaw AE/SAE reporting, ensuring prompt submission to sponsors and IRB/IEC.
- Managed end-to-end website and digital platform projects from requirements through deployment.
- Coordinated designers, developers, and stakeholders to deliver customer-facing web solutions.
- Accelerated study start-up timelines by 20% through efficient site activation and regulatory document collection.
Clinical Delivery Manager
ICON
03.2022 - 09.2022
- Independently managed monitoring activities across multiple clinical trial sites, ensuring continuous inspection readiness.
- Moderate technical discussions to resolve blockers and drive delivery progress.
- Produce weekly status reporting highlighting milestones, open risks, blockers, and dependency impacts.
- Review sprint actuals versus estimates and analyze Rally and Jira data to monitor velocity and spend projections.
- Reviewed and reconciled essential regulatory documents.
- Managed investigational product accountability with zero compliance findings.
- Oversaw AE/SAE reporting, ensuring timely submission to sponsors and IRB/IEC.
- Supported audit and inspection readiness activities with successful outcomes.
Clinical Research Associate
DFW Center for Spinal Disorders
11.2020 - 03.2022
- Conducted site monitoring visits and managed sensitive patient data, supporting study execution and milestone achievement.
- Ensured 100% compliance with HIPAA and regulatory standards.
- Supported protocol development and CRF design.
- Managed laboratory sample collection, processing, and shipment.
- Coordinated vendor activities and ensured prompt delivery of clinical supplies.
- Reviewed EDC systems for data integrity and resolved discrepancies.
- Delivered 100% on-time monitoring reports and follow-up letters.
- Reduced protocol deviations by ~20% through proactive risk identification and mitigation.
Clinical Project Coordinator
Aerotex/Pharmatex Research
12.2018 - 11.2020
- Screened and enrolled study participants and supported correct documentation, and optimized workflows.
- Educated participants on informed consent, study procedures, and visit schedules.
- Coordinated investigational product handling, specimen collection, and shipment.
- Maintained correct source documentation and regulatory records.
- Collaborated with investigators and study teams to resolve participant-related issues.
- Maintained project plans, dependency logs, and risk trackers.
- Identified and mitigated technical and timeline risks to preserve release schedules.
Education
Bachelor of Arts - Psychology
University of Massachusetts
BostonSkills
- Clinical Monitoring
- Regulatory Compliance
- Audit & Inspection Readiness
- SAE/AE Reporting
- Protocol Deviation Management
- Project Management
- Site Management
- Vendor Management
- Cross-Functional Collaboration
- Data Integrity
- Medidata RAVE
- Oracle InForm
- Veeva Vault eTMF
- Microsoft Office Suite
- Atlassian Tools
- Rally
- Jira
- Microsoft Excel
- Microsoft Word
- Microsoft PowerPoint
- Strong Communication
- Problem Solving
- Time Management
- Critical Thinking
- Stakeholder Management
- Independent Monitoring
- Patient Safety Focus
Certifications Education
- Bachelor of Arts in Psychology, University of Massachusetts - Boston
- Clinical Research Associate (CRA) Certification, Parexel Academy, 2025
- Professional Scrum Master
- Certified Scrum Master
- Project Management Professional
Core Competencies
Clinical Monitoring, Regulatory Compliance (FDA, ICH-GCP), Audit & Inspection Readiness, SAE/AE Reporting, Protocol Deviation Management, Project Management, Site Management, Vendor Management, Cross-Functional Collaboration, Data Integrity, Medidata RAVE, Oracle InForm, Veeva Vault eTMF, Microsoft Office Suite, Atlassian Tools
Timeline
Project Manager
BrightSpring Health Services
10.2022 - Current
Clinical Delivery Manager
ICON
03.2022 - 09.2022
Clinical Research Associate
DFW Center for Spinal Disorders
11.2020 - 03.2022
Clinical Project Coordinator
Aerotex/Pharmatex Research
12.2018 - 11.2020
Bachelor of Arts - Psychology
University of Massachusetts