Protocol Manager Braine-l'Alleud, Belgium
Since February 2017
- Strong operational understanding of conducting clinical trials.
- Coordination and contribution to key clinical documents (e.g. Protocols).
- Establishement and upholding of an effective dialogue with sponsor, investigators, investigative site personnel, Field Medical Science Liaisons, and external vendors.
- Flexibility and management of studies across organization ( i.e. multiple Therapeutic Areas)
- Ability to identify potential barriers and mitigation strategies to site start-up
- Participation in interactions among many different groups including Field Medical Science, Medical Information, Biomarker Team, Global Biostatistics, GCR, and GDO.
- Process improvement, implementation of departmental standard practices and processes
- Project management as a whole
Laboratory Study Manager
March 2010 --- January 2017
•Participation in reviewing Protocol on an operational laboratory point of view : contact with the lab managers to check feasibility of the study regarding workload; check Test IDs; check type of samples, method of sampling, material and device to use; decision-taking : use or not of central laboratory •Review of Bid proposal to work with Central Labs •Set-up of the study with a Central Lab (Barc, Quest Diagnostics): review of laboratory worksheet, lab manual, requisition forms. Overview of sample management and shipments. •Collaboration with external laboratories for result reporting (CEVAC, DDL, Immunehealth) •Follow-up of study set-up internally (all teams have all information available to set up the study in the system; use of SAP) •Due dates : review of due dates per study, check if timings fit (article 46!) ; follow-up with the labs, negotiation with Clinical team and Labs if delay foreseen •Review of laboratory listings (histopathology) •Interaction with the Data Management to create Laboratory Applications; help in sample reconciliation •Monitoring of Lab files (Source Document Verification, Paperwork vs Listings)
Clinical Trial Assistant (CTA)
February 2008 --- January 2010
•Participation in reviewing Protocol/ICF, CRF, CRF filling guidelines, Monitoring guidelines, Study leaflet and SOPs •CTA Activities: Master Contact list (preparation, distribution, update), Investigator Meeting organization (binders, agenda), Investigator File preparation (EC approval, protocol, agreements, IB, study leaflet), Trial Master File completion and up-to-date follow up, certification collection, collection of reports (pre-study contact, site evaluation, site initiation, site monitoring), Pharmacovigilance – clinical safety acquaintance (SAE listings, reconciliation listings/ SAE database), IMP tracking, sera collection, aliquots preparation and transfer to lab, general management of documents (filing, collection, signature QC), QC File (tracking of documents through excel sheet), archiving •Close interaction with CRAs (DRQFs, PDFs, CVs recollection; document tracking) throughout the study
August 2004 --- January 2008
Training in phlebotomy, hematological analysis (homeostasis, cytology, hematology, liquid analysis), chemical analysis, immuno-hematology, basic secretarial knowledge.
Specialist in Herbal Medicine from IFAPME Mons in 2016
Bachelor of Science (B.Sc.) in Biomedical Sciences, General from HEMES Saint-Laurent Liège in 2004
in Biomedical Sciences, General from FUNDP Namur in 2002
in Scientific and Medical Aromatherapy from International College of Aromatherapy in 0
in from International School of Choueifat in 0
Training and Certification
GCLP Training in 2015 Training
GCP Training in 2008 Training