Description

English:

Experienced CRA with 3 years in clinical trial monitoring for startup companies, across more than 12 investigational sites in Europe. Skilled in on-site and remote monitoring, data cleaning, and audit preparation, including ANSM inspections. Strong understanding of ICH-GCP and French/EU clinical regulatory requirements. Proven ability to manage multiple sites and support project coordination activities, ensuring compliance, data integrity, and timely execution of clinical trials.

Monitoring activities: site initiation visits, close out visits, interim monitoring visits, audit preparation visits

Francais:

ARC expérimentée avec 3 ans d’expérience dans la recherche clinique, ayant assuré le monitoring de plus de 12 centres investigateurs en Europe. Compétences confirmées en monitoring sur site et à distance, "data cleaning", et préparation d’audits (notamment inspections ANSM). Solide connaissance des exigences réglementaires françaises et européennes (ICH-GCP). Capacité avérée à gérer plusieurs sites simultanément et à contribuer à la coordination de projet, dans le respect des délais, de la qualité et de la conformité.

Domaines d’expertise

Langues

Anglais
Bilingue ou natif
Français
Bilingue ou natif

Préférences en matière de lieu de travail

Accepte de travailler sur site

Paris (jusqu’à 50 km)

CARDIAWAVE
Clinical Research Specialist
INDUSTRIE PHARMACEUTIQUE
octobre 2022 - Aujourd'hui (3 ans et 8 mois)
Class IIb Medical Device
End date: 9 September 2025
• Project Management: writing clinical protocols, document preparation for CE marking study (CIR, Progress Reports, Interim Study reports, Safety Management Plan,…), working closely with clinical research organisation (CRO), corelabs and medical professionals, payment overview reports/budget planning, safety data management and safety reporting, knowledge on GDPR/MDR, DSMB/CEC meeting preparation (as CEC facilitator) and writing monthly/quarterly reports, ANSM audit preparation; Budget planning for clinical sites/clinical projects

• CRA activities: clinical data monitoring, query resolution, troubleshooting, eCRF creation, ISO 14155, preparations for database lock, primary contact with 12 investigation sites across Europe

• Clinical Applications: writing clinical study observation reports, training interventional cardiologists and echocardiologists on the device, presenting and analysing data to research groups, participating in publications, logistics planning
CAIRDAC
Product Development Engineer
mai 2021 - septembre 2022 (1 an et 4 mois)
Class III Medical Device
• Development and assembly of leadless pacemaker and delivery tool (Project Leader of Delivery Tool): explantation studies, in vitro and in vivo testing, design evolution
• Pre-clinical trial operating room experience: acute and chronic studies on live swine & human cadavers, walking through procedures with cardiologists during intervention, communication with cardiologists on the device functionality & handling, assessing device interaction with blood/movement of heartbeat, animal models (pigs, sheep, human cadavers)
• Pre-clinical trial evaluations – clinical protocols, post-processing data (Matlab, R, IGOR), expertise reports of device functionality, documentation FDA & MDR (audits), data monitoring
• LabChart/PowerLab ECG data acquisition – pacemaker sensing, stimulation + pacing, post-processing ECG on Matlab, presenting results to team + planning future objectives, DICOM file analysis (EzDicom imaging software)
• Conceptualising technical and normative tests for medical device + bench test designing
• Application and in depth knowledge of norms: ISO 10993, ISO 13485, ISO 10555
• In charge of quality work instructions/procedures for laboratory procedures
• Biomechanics & Informatics: laser welding, tensile testing, dimensional control, accelerometers, cardiac signals…
• Working synergetically with electronic, quality, preclinical and mechanical teams