Modiri Monkangwo
Brussels
Summary
Proficient Clinical Research Professional with strong background in clinical research methodologies and regulatory compliance. Managed multiple clinical trials, ensuring adherence to protocols and ethical standards. Demonstrated capabilities in data analysis and patient coordination.
Overview
19
19
years of professional experience
Work History
Health and Nutrition Consultant
freelance
10.2022 - Current
- Delivered evidence-based health programmes focusing on fatigue, chronic conditions, and sickle cell disease.
- Collaborated with patient associations to devise educational modules and preventive strategies to bolster patient education and crisis prevention.
- Managed projects, training sessions, and scientific communication initiatives, thereby reinforcing transferable skills for healthcare leadership.
Clinical Trial Supply Manager - Consultant
GSK
08.2021 - 11.2021
- Oversaw clinical supply operations from protocol draft to study closeout, ensuring the seamless execution of feasibility assessments, implementation, and monitoring of logistics activities.
- Defined logistical strategies encompassing supply, distribution, and randomisation.
- Coordinated efforts between global and local teams to ensure the timely achievement of study milestones.
Data Manager
Institut Jules Bordet
09.2017 - 08.2021
- Ensured data accuracy and adherence to regulatory compliance (ICH-GCP).
- Engineered data collection tools and contributed to departmental SOPs, enhancing data collection processes.
- Implemented risk management strategies to safeguard clinical study deliverables.
Clinical Research Coordinator
Cliniques Universitaires Saint-Luc
07.2017 - 09.2017
- Coordinated over 20 sponsor-funded and academic paediatric clinical trials, ensuring rigorous compliance with study protocols.
- Managed budgets, logistics, patient inclusion/exclusion criteria, and safety monitoring processes.
- Liaised effectively with pharmacy, laboratories, ethics committees, and care units to facilitate trial operations.
Clinical Laboratory Study Manager – Expert Consultant
GSK
01.2014 - 06.2016
- Managed large-scale vaccine programmes within the Malaria Project, overseeing over 15 clinical studies in Africa, including collaborations with WHO, Bill & Melinda Gates Foundation, GAVI, and PATH.org.
- Conducted five epidemiological studies under the Dengue Project across ASPAC and Latin America.
- Oversaw two clinical studies focused on Respiratory Syncytial Virus (RSV) in Europe.
- Acted as the global operational point of contact for all GSK Vaccines stakeholders, ensuring alignment and communication.
- Managed all operational lab-related activities, coordinating with external partners and vendors for seamless workflow.
- Defined and analysed KPIs, identifying trends and ensuring prompt resolution of issues.
- Ensured daily deliverables and study milestones adhered to all standards and project requirements.
- Assisted and trained Local Operating Sites in the management and monitoring of Human Biological samples and laboratory-related activities.
Data Management Associate – Consultant
GSK
05.2012 - 01.2014
- Appointed as team supervisor, balancing priorities, leading team meetings, and providing training to team members.
- Supervised data management team operations, optimising team performance.
- Defined KPIs and spearheaded process improvements.
Surveillance and Vigilance Specialist EMEA
Baxter Healthcare
08.2011 - 12.2011
- Managed product complaints within the Renal and Medical Delivery Division across EMEA, ensuring compliance and safety.
- Monitored the safety, efficacy, and quality of products throughout their usage period.
- Determined MEDDEV reportability and submitted relevant reports to the applicable authorities.
- Coordinated investigation activities in line with reporting requirements.
- Identified and communicated potential adverse events regarding therapeutic products to Pharmacovigilance Units.
- Analysed trends according to Corrective and Preventive Actions (CAPA) requirements and provided recommendations.
- Trained local coordinators on applicable procedures to ensure compliance.
Clinical Data Manager – Consultant
GSK
05.2009 - 07.2011
- Led the Flu Vaccine Project, responsible for over 20 clinical studies.
- Published findings in the Pediatric Infectious Disease journal, specifically on the H1N1 pandemic influenza vaccine study.
- Managed the cleaning, reconciliation, and reporting of databases, predominantly focused on pandemic influenza vaccine projects.
- Identified and resolved data inconsistencies within the clinical database.
- Reviewed data and executed all ancillary cleaning reports to ensure data integrity, organising and leading post-cleaning meetings with the clinical research study team.
- Issued comprehensive final cleaning reports to all relevant members of the clinical research study.
Complaints Specialist
Cordis
05.2008 - 04.2009
- Served as a representative of the Complaint Handling and Safety Surveillance Team in Europe for a former Johnson & Johnson company.
- Identified all missed reportable complaints, resolving collaboration issues between the US-based Complaint Handling team and the Clinical Department team in Europe.
- Responsible for enhancing the reconciliation process through effective project management.
- Implemented a user-friendly database tool in conjunction with the IT support team.
- Developed training materials for local and external colleagues regarding the complaint reporting process, successfully delivering training sessions.
- Analysed reports to identify underlying issues, initiating actions to tackle root causes and integrate them into the Quality Management Systems (QMS).
External Lab Coordinator
GSK
01.2007 - 04.2008
- Accountable for the processing, storage, and shipment of Human Biological Samples from clinical sites to delegated laboratories, adhering rigorously to protocols and GMP procedures.
- Managed logistics strategy and consolidation of pick-ups under challenging timelines and stringent temperature constraints.
- Devised cost-saving strategies while maintaining high levels of quality, security, and compliance with all requirements.
- Oversaw the supply chain, cold chain management, and handling procedures, ensuring stringent cold chain regulations.
- Developed and implemented technical solutions for pick-up and shipment services and related equipment.
- Collaborated with procurement for the selection of couriers and suppliers, aligning on goals and standards.
- Defined strategic flows for sample management and implemented cross-functional logistics requirements to support clinical study initiation.
- Established robust communication channels between multi-disciplinary teams and geographically remote customers and suppliers.
Clinical Project Assistant
GSK
10.2007 - 01.2008
- Supported four Project Managers in managing multiple clinical projects, ensuring the smooth operational execution of each initiative.
- Gathered and consolidated relevant information for project stakeholders, providing timely updates on study progress and current issues.
- Tracked milestones and issues for projects, holding responsibility for monthly project tracking reports, including budget payments and study budget breakdown signatures.
- Prepared comprehensive financial reports and forecasts to inform project planning.
Clinical Safety Associate
GSK
01.2007 - 09.2007
- Engaged in pharmacovigilance related to the HPV (Human Papilloma Virus) vaccine, managing adverse and serious adverse event reports.
- Responsible for the collection and assessment of all adverse event data, as well as identifying clinically significant information regarding causality.
- Ensured accurate coding of reports within the database using standard terminology prescribed by global regulatory authorities (MedDRA safety dictionary and WHO-drug coding).
- Prepared safety files for submission to authorities as required.
Education
Nutritional Therapy Certificate -
Cerden
Brussels06-2018
Post Graduate Programme - Pharmaceutical Medicine & Drug Development Sciences
Pharmed
Brussels09-2012
Bachelor degree - Biochemistry
Institut R. Lambion
Brussels06-1998
Skills
- Clinical Data Management
- Trial Operations
- QMS & CAPA
- ICH-GCP
- Project Management
- IWRS
- eTrack
- Microsoft Word, Excel, PowerPoint
- Clinical nutrition
Languages
French
Bilingual or Proficient (C2)
English
Upper intermediate (B2)
Timeline
Health and Nutrition Consultant
freelance
10.2022 - Current
Clinical Trial Supply Manager - Consultant
GSK
08.2021 - 11.2021
Data Manager
Institut Jules Bordet
09.2017 - 08.2021
Clinical Research Coordinator
Cliniques Universitaires Saint-Luc
07.2017 - 09.2017
Clinical Laboratory Study Manager – Expert Consultant
GSK
01.2014 - 06.2016
Data Management Associate – Consultant
GSK
05.2012 - 01.2014
Surveillance and Vigilance Specialist EMEA
Baxter Healthcare
08.2011 - 12.2011
Clinical Data Manager – Consultant
GSK
05.2009 - 07.2011
Complaints Specialist
Cordis
05.2008 - 04.2009
Clinical Project Assistant
GSK
10.2007 - 01.2008
External Lab Coordinator
GSK
01.2007 - 04.2008
Clinical Safety Associate
GSK
01.2007 - 09.2007
Nutritional Therapy Certificate -
Cerden
Post Graduate Programme - Pharmaceutical Medicine & Drug Development Sciences
Pharmed
Bachelor degree - Biochemistry
Institut R. Lambion