Joseph Onyeanu
Delivering high-quality clinical trials. Strengthening research sites. Building partnerships that make studies possible.
Clinical Research Associate with 8+ years managing and monitoring Phase II–IV multicentre trials across hematology, nephrology, neurology, cardiovascular and medical-device programs — leading end-to-end site management under ICH-GCP, FDA and EMA standards.
8+
YEARS IN CLINICAL RESEARCH
7+
PHASE II–IV TRIALS MONITORED
10
AFRICAN COUNTRIES — SITE ALLIANCE
35%
SITE CAPACITY GROWTH IN 90 DAYS
Protecting patient safety and data integrity while helping sites perform at their best.
I manage the full clinical-trial lifecycle — from feasibility and site activation through monitoring to close-out — keeping studies on schedule while meeting protocol, sponsor and regulatory requirements. My work spans Site Qualification, Initiation, Interim Monitoring and Close-Out visits, source data verification and risk-based monitoring.
Across Phase II–IV multicentre programs, I've maintained 100% audit-ready Trial Master Files and essential documents, resolved protocol deviations through effective CAPA, and partnered with sponsors, investigators, CROs, medical monitors and data management to deliver quality studies.
Beyond monitoring, I build strategic site partnerships across Sub-Saharan Africa, mentor junior CRAs, and represent clinical research at industry forums, strengthening investigator relationships and expanding trial-ready capacity in the region.
Therapeutic Areas
Compliance Frameworks
- ICH-GCP compliance
- FDA regulations
- EMA guidelines
- Inspection readiness & CAPA
Four capability areas that run a study end to end.
Clinical Trial Monitoring
SQV, SIV, interim and close-out visits with rigorous source data verification and risk-based oversight — on-site and remote.
Site & Investigator Management
Feasibility, activation and performance oversight, with long-term relationships built with PIs, KOLs and institutional leadership.
Regulatory & Quality
Audit-ready Trial Master Files and essential documents, protocol compliance, inspection readiness and CAPA management.
Safety & Data Integrity
Timely SAE reporting, patient-safety oversight, protocol-deviation management and CRF query resolution that protect data quality.
Selected, verifiable outcomes.
Led clinical monitoring across 7+ international Phase II–IV multicentre trials spanning Nigeria and Sub-Saharan Africa.
Managed a portfolio of 8–10 investigative sites, performing comprehensive SDV, SDR and risk-based monitoring.
Maintained 100% audit-ready TMFs, ISFs and essential documents, supporting successful sponsor audits and regulatory inspections.
Expanded access to trial-ready sites and experienced investigators by 35% within 90 days.
Established strategic research partnerships with institutions across 10 African countries.
Mentored and coached 5+ junior CRAs, strengthening monitoring quality and regulatory compliance.
Implemented effective CAPA that minimised repeat findings and improved overall site compliance.
Progression at Xcene Research.
Strategic Site Alliance Leadership
2026–PresentXCENE Research
- Supported planning, coordination and execution of Phase II–IV studies in compliance with ICH-GCP and applicable regulations.
- Maintained Trial Master Files and CTMS in an inspection-ready state through accurate filing, tracking and quality control.
- Assisted CRAs with SQV, SIV, IMV and co-monitoring, and supported site activation and essential document collection.
Senior Clinical Research Associate
2022–PresentXCENE Research
- Led clinical monitoring across 7+ Phase II–IV multicentre trials, overseeing site performance, quality compliance and sponsor relationships across Sub-Saharan Africa.
- Directed end-to-end site management from feasibility and qualification through study close-out, on schedule and in line with protocol and regulatory requirements.
- Managed 8–10 investigative sites with comprehensive SDV, SDR and RBM/RBQM; maintained 100% audit-ready TMFs, ISFs and CTMS records.
- Mentored 5+ junior CRAs and delivered investigator meetings, site-initiation training and GCP education across multiple studies.
Clinical Trial Associate
2017–2019XCENE Research
- Establish and manage strategic research partnerships across ten African countries.
- Conduct site feasibility and capability assessments — investigator expertise, recruitment potential, lab capability, infrastructure and regulatory readiness.
- Build long-term relationships with Principal Investigators, KOLs and institutional leadership.
- Expanded organizational access to trial-ready sites and investigators by 35% within 90 days.
Therapeutic experience across five areas.
My clinical research experience spans multiple therapeutic areas, giving me exposure to different patient populations, study designs, site environments, and operational considerations.
Sickle Cell Disease
Hematology monitoring and site management.
APOL1-Mediated Kidney Disease
Nephrology trial oversight and quality compliance.
Stroke Prevention
Neurology study monitoring and safety oversight.
Cardiovascular Disease
Cardiovascular program site monitoring.
Medical Device Studies
Device clinical studies and inspection readiness.
Representing clinical research where stakeholders convene.
Facilitation and company representation at forums bringing together regulators, investigators, researchers, biotech and pharmaceutical organizations.
Nephrology Workshops
Lead facilitator for nephrology workshops at the Impact Africa Summit, engaging regulators, investigators, researchers, and biotech and pharmaceutical stakeholders in discussions around clinical research.
Academy for Sickle Cell & Thalassemia
Led Xcene Research's participation and capabilities presentation at the Academy for Sickle Cell & Thalassemia, representing the organization and engaging clinical and research stakeholders.
Education & Certifications.
Education
MBA — Clinical Research Management
Rushford Business School
Expected Autumn 2026
Bachelor of Technology — Biotechnology
Federal University of Technology, Owerri
2012
Certifications
Good Clinical Practice (GCP)
Association of Clinical Research Professionals
2026
Strategic Leadership
London School of Business Administration
2025
Clinical Research
Regulatory & Quality