Open To Work
Augustina Ekhaiyeme
Mooresville,North Carolina
Summary
Clinical Trial Manager with 10+ years of progressive experience leading Phase I–IV clinical trials across oncology, CNS (Alzheimer’s), infectious diseases, vaccines, and pediatric populations. Proven track record of managing studies from startup through closeout, with strong ownership of timelines, budgets, site performance, and regulatory compliance. Experienced in leading cross-functional teams, overseeing CRAs and site operations, and partnering with sponsors to deliver high-quality data while maintaining patient safety and protocol integrity. Brings a practical, solutions-driven approach to study execution, with strengths in risk management, process improvement, and operational efficiency. Recognized for accelerating site activation, improving enrollment performance, and contributing to program growth in both CRO and site environments.
Overview
1
1
Certification
10
10
years of professional experience
Work History
Clinical Trial Manager (CTM)
Immorna Biotherapeutics Inc
Morrisville, NC
01.2025 - Current
- Participates in planning and Protocol Development: Develops case report forms (CRFs) and informed consent documents, ensuring all study materials comply with Good Clinical Practice (GCP) and regulatory standards.
- Trial Coordination and Site Management: Identifies, selects, and initiates clinical trial sites, coordinating with investigators, site staff, and ethics committees. Supervises trial teams across multiple sites, provides training, and ensures adherence to study protocols.
- Monitoring and Data Oversight: Monitors trial progress, manages data collection, and ensures accuracy and completeness. Oversees clinical research associates (CRAs) and data managers, reviews case report forms, and collaborates with statisticians to analyze results.
- Regulatory Compliance and Ethics: Ensuring trials comply with local, national, and international regulations is a key duty. Coordinates with regulatory authorities, ethical committees, and sponsors to maintain participant safety and ethical standards.
- Budget and Resource Management: Creates and manages trial budgets, oversees site payments, vendor contracts, and resource allocation, ensuring projects remain on schedule and within financial constraints.
- Reporting and Documentation: Archives study documentation, communicates progress to stakeholders, and implements quality control measures, including audits to maintain compliance.
- Stakeholder Communication: Serves as the primary point of contact for investigators, sponsors, vendors, and internal teams, facilitating collaboration and addressing challenges throughout the trial lifecycle.
Clinical Trial Manager (CTM)
PharPoint Research
Durham, NC
03.2023 - 01.2025
- Oversee the day-to-day management of Phase I–III trials, ensuring studies move efficiently from startup through closeout while meeting regulatory and sponsor expectations.
- Lead cross-functional teams (CRAs, CTAs, data management, regulatory), keeping timelines on track and maintaining clear communication across stakeholders.
- Support and mentor CRAs across multiple sites, improving monitoring consistency, reducing query turnaround time, and strengthening site relationships.
- Drive site activation activities, including feasibility, selection, and initiation, helping shorten startup timelines through proactive planning.
- Serve as the main point of contact for sponsors, managing expectations, resolving issues early, and maintaining study momentum.
- Track study progress against timelines and budgets, identifying risks early, and implementing practical solutions to keep deliverables on schedule.
- Contribute to key study documents (monitoring plans, risk plans, SOPs) and ensure alignment with protocol and regulatory requirements.
- Maintain audit readiness across studies, supporting sponsor and regulatory inspections with strong outcomes.
- Partner with data management and biostatistics teams to support clean data and timely database lock.
- Participate in bid defenses and proposal development, contributing operational insight during business development effort.
Snr Clinical Research Associate (Snr CRA)
PharPoint Research
Durham, NC
03.2021 - 02.2023
- Managed multiple Phase II–IV studies across diverse sites, ensuring compliance with protocols, GCP, and regulatory requirements.
- Played a key role in site performance by identifying enrollment barriers and working closely with coordinators and investigators to improve recruitment.
- Maintained high data quality through thorough SDV/SDR and proactive query resolution.
- Acted as a trusted point of contact for sites, supporting both operational and regulatory needs.
- Recognized for identifying site risks early and helping implement corrective actions that improved overall study performance.
- Consistently delivered monitoring reports on time with clear, actionable insights for sponsors and internal teams.
Clinical Research Associate (CRA)
PharPoint Research
Durham, NC
03.2018 - 02.2021
- Conducted on-site and remote monitoring visits to ensure compliance with study protocols and regulatory requirements.
- Verified the accuracy and completeness of clinical data through source document verification (SDV) and CRF review.
- Ensured timely reporting of adverse events and protocol deviations, contributing to patient safety and regulatory compliance.
- Acted as the primary contact for study sites, providing ongoing support and addressing study-related inquiries.
- Collaborated with project management to ensure timely study deliverables and effective risk management strategies.
- Documented site status, findings, and follow-up actions in monitoring visit reports.
In-House Clinical Research Associate (CRA)
PharPoint Research
Durham, NC
02.2016 - 03.2018
- Assisted in providing comprehensive remote monitoring of clinical trial sites to ensure compliance with protocols and regulatory standards.
- Managed site communication, addressing queries and facilitating timely patient recruitment and data collection.
- Assisted in supporting study start-up activities, including regulatory document review, submission, and site initiation activities.
- Assisted in conducting regular site data reviews, tracking protocol deviations, and ensuring prompt reporting of adverse events.
Education
Doctor of Business Administration - Healthcare Management and Global Leadership
California Intercontinental University
02.2027
Skills
- Clinical Trial Management (Phase I–IV)
- Study Start-Up & Site Activation
- Cross-Functional Team Leadership
- CRA Oversight & Development
- Regulatory Compliance (FDA, ICH-GCP)
- Risk-Based Monitoring (RBM)
- Vendor & Site Management
- Budgeting & Contract Negotiation
- Timeline & Deliverables Management
- CTMS/EDC Systems
- Patient Recruitment & Retention Strategies
- Data Quality & Query Management
- Audit & Inspection Readiness
- SOP Development & Process Improvement
- Stakeholder Engagement (Sponsors, CROs, Investigators)
- Operational Strategy
Certification
- Doctoral Coursework Exit Assessment (Peregrine Global Service)
- Research Finance Training (Budgeting & Accounting)
- ICH-GCP (R3)
- Human Subject Research
- FDA Inspections
- Informed Consent and Clinical Investigations
- Biomedical PI
- Bloodborne Pathogens Infectious Disease Control Best Practices / Precautions
- IATA
Accomplishments And Honors
- Best Student in Clinicals, 2016-06-01, Irrua Specialist Teaching Hospital, Edo State, Nigeria
- Best Student in Hematology, 2016-09-01, Irrua Specialist Teaching Hospital, Edo State, Nigeria
Affiliations And Membership
- Member American Society of Clinical Pathology (ASCP)
- Member, Association of Clinical Research Professionals (ACRP)
- Member, Black Women in Clinical Research
References
References are available upon request.
Work Preference
Work Type
Full TimeLocation Preference
RemoteTimeline
Clinical Trial Manager (CTM)
Immorna Biotherapeutics Inc
01.2025 - Current
Clinical Trial Manager (CTM)
PharPoint Research
03.2023 - 01.2025
Snr Clinical Research Associate (Snr CRA)
PharPoint Research
03.2021 - 02.2023
Clinical Research Associate (CRA)
PharPoint Research
03.2018 - 02.2021
In-House Clinical Research Associate (CRA)
PharPoint Research
02.2016 - 03.2018
Doctor of Business Administration - Healthcare Management and Global Leadership
California Intercontinental University