Clinical Trial Manager
Open To Work
Augustina Ekhaiyeme
Immorna Biotherapeutics Inc
Mooresville,North Carolina
1
Certification
11
Years of experience
Clinical Trial Manager with 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.
Work History
Clinical Trial Manager (CTM)
1 Year 9 Months- • Lead end to end execution of multi-country oncology trials across the US, China, and Japan, directing cross-functional teams of up to 32 across CROs, vendors, and sites.
• Own study timelines, budgets, and site performance from startup through closeout, driving on-time activation and steady enrollment across global sites.
• Oversee CRAs and site operations, mentoring monitoring staff and strengthening data quality, query resolution, and protocol compliance.
• Serve as primary sponsor-facing contact, managing escalations, risk mitigation, and governance communications to protect patient safety and data integrity.
• Maintain inspection-ready trial master files and quality oversight across regions, ensuring alignment with FDA, ICH GCP, and local regulatory requirements.
Clinical Trial Manager (CTM)
1 Year 10 Months- 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)
1 Year 11 Months- 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)
2 Years 11 Months- 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)
2 Years 1 Month- 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
Skills
Clinical Trial Management
Oncology Clinical Trials
Vendor & Site Management
Study Start-Up & Site Activation
Cross-Functional Team Leadership
CRA Oversight & Development
Regulatory Compliance (FDA
ICH-GCP)
Risk-Based Monitoring (RBM)
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
Work Preference
Work Type
Full Time
Location Preference
Remote
References
References are available upon request.
Timeline
Clinical Trial Manager (CTM)
Immorna Biotherapeutics Inc
01.2025 - CurrentRead More
Clinical Trial Manager (CTM)
PharPoint Research
03.2023 - 01.2025Read More
Snr Clinical Research Associate (Snr CRA)
PharPoint Research
03.2021 - 02.2023Read More
Clinical Research Associate (CRA)
PharPoint Research
03.2018 - 02.2021Read More
In-House Clinical Research Associate (CRA)
PharPoint Research
02.2016 - 03.2018Read More
California Intercontinental University
Doctor of Business Administration from Healthcare Management and Global Leadership
Read More