
Joke Belza, PhD
Researcher Phd Candidate

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About me
Clinical Data Manager at Argenx | Clinical Consultant at Solcur
Education

Universiteit Gent en Vrije Universiteit Brussel (FWO Fellowship)
2010 - 2015Doctor of Philosophy (Ph.D.) Planetary Sciences; Analytical ChemistryPhD degree in Planetary sciences, focus on analytical method development, geo- and cosmochemistry

Universiteit Gent
2005 - 2010Bachelor and Master's degree Geology/Earth Science Magna cum laude
VIVES University College
2020 - 2020Clinical study coordinator HealthcareActivities and Societies: Post-graduate education program. Certificate of completion and passing final exam.
Experience

Vrije Universiteit Brussel and Ghent University, Research Foundation Flanders (FWO) (Joint Phd)
Oct 2010 - Sept 2015Researcher Phd Candidate
Ghent University- Dept. Of Biology- Functional Plant Biology Research Group
Dec 2015 - Aug 2017Associate ScientistTIME SCALE project (Horizon 2020 EU Research and Innovation programme): Technology and Innovation of Modular Equipment in Scalable Advanced Life Support Systems for Space Exploration. TIME SCALE aims to investigate how food crops grow in space, and whether they could realistically contribute a meaningful, long-term supply of food and oxygen to space travelers.My job was to provide scientific and technical support in the H2020 project: TIME SCALE “Technology and Innovation of Modular Equipment in Scalable Advanced Life Support Systems for Space Exploration”. TIME SCALE aims to investigate how food crops grow in space, and whether they could realistically contribute to a meaningful, long-term supply of food and oxygen to space travelers. In addition the project investigates applications on earth such as monitoring of suboptimal growth conditions caused by abiotic and biotic stress (drought, temperature, pathogens,…) leading to worldwide yield losses in cultivated crops. Core-tasks- Responsible for the development and validation of analytical methods for detecting volatile organic compounds released from crops (via SIFT-MS and GC-MS), and their evaluation as pre-symptomatic, biomarkers for abiotic stress- Responsible for technical and scientific evaluation of modular cultivation systems, active participation in project meetings and communication at project management level. Show less

Ghent University - Dept. Of Chemistry- Analytical and Atomic Mass Spectrometry Research Group
Sept 2017 - Aug 2020Postdoctoral ResearcherCore tasks: - Bio-team: responsible for analytical method development for 2D and 3D bio-imaging with LA-ICP-MS - Responsible for analytical method development for (ultra) trace elemental and isotopic analysis in bio-samples using wet chemistry techniques (sample pre-treatment in class 10 cleanlab, analysis via quad-based ICP-MS, multi-collector-ICP-MS, sector-field-ICP-MS, ICP-OES, triple-quad-ICP-MS)- Managing (communication, experimental design, measurement, reporting) of several research projects for external partners in the biotechnological, pharmaceutical and biomedical field - Teaching and guidance of students at the Bachelor, Master and PhD level http://www.ams.ugent.be/ Show less

IDDI
Nov 2020 - Mar 2023Lead Clinical Data ManagerIDDI (International Drug Development Institute) provides Biostatistical and eClinical services in Phase I to IV clinical trials. As Lead Clinical Data Manager, I was overseeing all deliverables and aspects of the data management process. - Reviewing the clinical study protocol and other supporting documentation from a database design perspective- Translating the protocol into an electronic CRF (eCRF database design)- Development of the Data Management Plan and Data Validation Plan- Discrepancy management/query resolution by review of clinical data for consistency (online edit checks, programmed SAS checks, manual review of clinical data listing)- Ensuring external data (Safety labs, imaging, pharmacokinetic data,...) are transferred and reconciled with the clinical database- Medical coding (WHODrug, MedDRA) and Serious Adverse Event (SAE) reconciliation- Performing database lock activities in close collaboration with sponsor, Project Coordinator/Manager, statistician and other parties.- Producing and maintaining study related key Data Management documentation- Contributing to Data Management process improvement- Communicating with the sponsor and other collaborators of the project regarding data management issues- Maintaining the accuracy, integrity and security of complex, large computerized clinical records systems- Applying extensive knowledge of drug development process, clinical trial regulations (ICH-GCP, FDA, EMA), protocols, procedures and industry standards (CDISC, SDTM) to control and maintain accurate recordsExperience in Phase-III clinical trials in immuno-oncology and rare diseases Show less

SolCur
Apr 2023 - nowClinical Consultant
Argenx
Apr 2023 - nowClinical Data Manager at Argenx | Clinical Consultant at Solcur
Licenses & Certifications

RECIST (Response Evaluation Criteria in Solid Tumors): A Practical Guide for Data Managers
ACDM: Association for Clinical Data ManagementDec 2020
Fundamentals of Clinical Data Management
ACDM: Association for Clinical Data ManagementDec 2020
49CFR 172.700/IATA 1.5, for the Shipping of Category A, Infectious Substance Affecting Humans Category B, Biological Substance
Mayo Clinic LaboratoriesFeb 2020.webp)
Foundational ICH-Good Clinical Practice (GCP) E6 (R2) Training- Certificate of Achievement with Excellence
European Centre for Clinical Research Training (ECCRT)Jan 2021
ICH GCP (ICH E6 GCP investigator site training)
IQVIAFeb 2020
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