Clinical Research & Operations

Dr. Chinyere
Chioma Nganwuchu

Clinical Research & Operations Manager  ·  PhD Life Science

Delivering end-to-end clinical research excellence across NHS, CRO, and academic settings — with the scientific depth and operational precision to make complex programmes succeed.

£2M+
Grant Managed
28+
Hospital Sites
4+
Publications
10+
Years Experience
Dr. Chinyere Chioma Nganwuchu
Who I Am

A Scientist. A Leader.
A Research Architect.

I am Dr. Chinyere Chioma Nganwuchu — a Clinical Research and Operations Manager with a PhD in Life Science and a distinguished track record across NHS, academic, and CRO settings. My work sits at the intersection of rigorous science, operational excellence, and patient-centred research.

From leading multi-site international cluster randomised trials across the UK and Kenya to managing £2M+ research grants and driving regulatory submissions through MHRA, HRA, and IRAS — I bring both the scientific depth and the operational precision to make complex research programmes succeed.

As the founder of PanthaCore Consulting, I offer bespoke clinical research consultancy — helping biotech, pharma, CROs, and academic institutions design, deliver, and scale high-impact studies with integrity and efficiency. Whether you need full end-to-end study management or targeted support on a specific component, I bring a collaborative, knowledgeable, and pragmatic approach to every engagement.

ICH-GCP E6(R3) MHRA / HRA / IRAS REDCap eTMF Management Regulatory Affairs Multi-site Trial Management SoECAT Budgeting MedTech Trials PPIE Informed Consent Phlebotomy Safety Reporting / CAPA
PanthaCore Consulting Logo
Collaborate. Innovate. Deliver.

A specialist clinical research consultancy offering end-to-end trial management, regulatory strategy, site readiness, and research operations support to NHS trusts, CROs, academic institutions, and MedTech sponsors.

Sectors Served
  • Biotech & Pharmaceutical Companies
  • Contract Research Organisations (CROs)
  • NHS Trusts & Academic Institutions
  • MedTech & Medical Device Sponsors
  • International Research Networks
What We Offer

How PanthaCore Consulting
Can Support You

I support biotech, pharma, CROs, and academic research teams with end-to-end clinical study delivery — or targeted support on specific study components. Every engagement is tailored, pragmatic, and built around your study's unique needs.

📋
Clinical Study Setup & Regulatory Support
  • Feasibility assessments & site readiness reviews
  • Protocol design, scientific review & optimisation
  • Support with substantial amendments & document updates
  • HRA, IRAS, Ethics & regulatory submissions
  • Interactive costing tools & budget development for study set-up
🗂️
Study Documentation & Quality Frameworks
  • CRF and eCRF design (including commercial databases)
  • Development of Monitoring Plans, Data Management Plans & Risk Assessment Plans
  • Creation of SOPs, Work Practice Documents (WPDs) & study templates
  • TMF / ISF setup and essential document readiness
  • Vendor coordination and SIV / site activation support
🔭
Project & Trial Management
  • End-to-end project oversight from initiation to close-out
  • Timeline tracking, risk management & stakeholder engagement
  • Cross-functional coordination with NHS sites, CROs, labs & vendors
  • Budget forecasting, contract coordination & financial tracking
📊
Recruitment, Data & Monitoring Excellence
  • Development of patient recruitment strategies for new & ongoing studies
  • On-site and remote monitoring with GCP compliance
  • Data integrity oversight, audits & quality checks
  • Safety reporting, issue escalation & CAPA support
Close-Out & Reporting
  • TMF reconciliation, archiving & study close-down
  • Final reporting support & contributions to publications
  • Lessons-learned reviews for operational improvement
Scholarly Work

Publications & Presentations

01
Targeting TGF-β Signalling Pathway for Resolution of Pulmonary Arterial Hypertension
Trends in Pharmacological Sciences
IF 13.5
02
Resolution of Coronavirus Disease 2019 (COVID-19)
Expert Review of Anti-Infective Therapy Journal
IF 3.25
03
Tackling the COVID-19 Pandemic — A Review
Journal of Bioscience
IF 1.83
04
Therapeutic Resolution of PAH Using Natural Products
Virtual Poster · University of Bradford Postgraduate Symposium
Poster
Career

Professional Experience

Nottingham Clinical Trials Unit · Contract
Clinical Trial Manager
International Multi-site RCT · Maternity & Prenatal Care
Multi-site Cluster Randomised Trial — UK & Kenya
  • Led set-up and delivery of a multi-site international cluster randomised trial across the UK and Kenya, managing study activation, baseline data collection, and site randomisation across 28 hospital sites.
  • Recruited, line managed, and coordinated an in-country research team in Kenya, ensuring robust cross-site collaboration and consistent protocol adherence.
  • Managed a £2M grant, overseeing budget allocation, financial tracking, and reporting to funders.
  • Led all ethical and regulatory submissions across UK and Kenyan approvals — national, county, and site-level — ensuring seamless and timely activation.
  • Developed key trial documentation (risk assessments, monitoring plans, CRFs) and delivered training for PIs, research nurses, and clinical teams.
  • Oversaw project timelines using Gantt charts and chaired governance meetings (TMG, TSC, DMC), ensuring all milestones and reporting requirements were met.
  • Collaborated with multidisciplinary stakeholders to develop REDCap data systems, deliver training resources, and support PPIE and capacity-building initiatives.
Clinical Research Solutions · CRO
Clinical Research Operations Lead
MedTech · Robotic-Assisted Surgery · CRC, Urology, GI & Gynaecology
Single-site Clinical Investigation · MHRA-regulated
  • Served as primary operational lead for a MedTech robotic-assisted surgery investigation, acting as the central point of contact for sponsors, CROs, sites, and investigators.
  • Led regulatory submissions and substantial amendments for complex protocol revisions under UK MDR 2002 and MHRA frameworks.
  • Managed the full clinical trial lifecycle from start-up to close-out, including eTMF management, document control, IRAS submissions, contracting, and inspection readiness.
  • Managed SAEs, AEs, and protocol deviations, developing SOP improvements and CAPAs to mitigate safety risks and drive study performance.
  • Ensured compliance with ICH-GCP, HRA, GDPR, HTA, and NHS Research Governance frameworks throughout the investigation.
Manchester University Foundation NHS Trust · NIHR CRF
Senior Clinical Research Lead
Oncology · Gastroenterology · Infectious Disease · Public Health
Studies: TRACC, SCOTTY, NHS-CVLP, ROSSINI 2, COLO-COHORT
  • Led operational delivery of multiple concurrent clinical trials across colorectal oncology, IBD, gastroenterology, infectious disease, and public health at a high-volume NIHR Clinical Research Facility.
  • Line managed Band 3 and 4 research practitioners, providing clinical supervision, performance oversight, and professional development.
  • Screened, recruited, and randomised eligible participants across complex trial protocols; reported genomic and pathology analysis results to trial teams.
  • Acted as the site lead for all sponsor and PI communications, managing queries and escalations to ensure protocol integrity and participant safety.
University of Bradford · Pre-Clinical Research Laboratory
Translational Research Project Manager
Molecular Biology · Pharmacology · Drug Development
  • Led preclinical research programmes investigating BMP/TGF-β signalling mechanisms in pulmonary arterial hypertension and cancer progression — contributing to high-impact publications.
  • Executed advanced molecular biology techniques including PCR/qPCR, Western blot, flow cytometry, confocal microscopy, and HPLC/LCMS analytical methods.
  • Applied quantitative systems pharmacology (QSP) and toxicology (QST) modelling to translate in vitro data into clinical safety risk assessments for drug development pipelines.
  • Managed multi-disciplinary research projects from experimental design through data analysis and publication, working within ICH-GCP and COSHH guidelines.
Qualifications

Education & Development

PhD · Life Science
Translational Research · Pharmacology · Molecular Biology
University of Bradford
MSc · Drug Toxicology & Safety Pharmacology
Safety Assessment · Preclinical Science
Institute of Cancer Therapeutics
BSc · Biochemistry
Molecular Biochemistry · Cellular Biology
University of Port Harcourt, Nigeria
Continuous Professional Development
7+ Certified Training Programmes
See Awards & Certifications ↓
Recognition

Certifications & Professional Awards

🎓
Associate Fellowship of the Higher Education Academy
HEA · 2026
Good Clinical Practice Certification E6(R3)
NIHR · Feb 2026
📑
AcoRD Cost Attribution Training
NIHR · Health & Social Care Costing · Oct 2025
🏥
Clinical Trial Management Training
NHS Research & Innovation · Oct 2024
💉
Venepuncture & Phlebotomy Competency
NHS Clinical Training · Sept 2024
🌟
Edward Jenner NHS Leadership Programme
NHS Leadership Academy · Courses 0, 1 & 2 · July 2024
📋
Informed Consent Certification
NIHR/NHS · Incapacitated Adults, Minors & Remote Consent · Feb 2024
Testimonials

What Colleagues Say

"

Chi is always a pleasure to work with, organised and knowledgeable with an impeccable work ethic. She understands clinical trials end to end, including clinical delivery, meaning she has an excellent understanding of the whole process, from regulatory standards to the more pragmatic aspects of clinical trials. I would highly recommend Chi to any company requiring clinical trial support.

LH
Liz Hawes
CEO at Clinical Research Solutions · Bespoke CRO Services for Clinical Evidence Generation of Healthcare Products
April 2026 · Direct Manager
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Get In Touch

Let's Work Together

Whether you need a full study management partner or targeted support on a specific phase of your research — PanthaCore Consulting is ready to collaborate. Get in touch to discuss your project needs.