Description

Besoin d'une ressource ponctuelle ou long-terme?

Passionnée d'essais cliniques et véritable couteau-suisse, j'aime coordonner des projets et mettre mon expérience au profit des entreprises qui souhaitent faciliter les essais cliniques aux investigateurs et aux patients.

Mon objectif: contribuer au développement de thérapies innovantes pour guérir ou améliorer la santé et le bien-être des patients.

Domaines d’expertise

Langues

Français
Bilingue ou natif
Anglais
Capacité professionnelle complète

Préférences en matière de lieu de travail

Accepte de travailler sur site

Montpellier (jusqu’à 50 km)

Nexbiome Therapeutics
Clinical Development Head / Senior Clinical Project Manager
BIOTECHNOLOGIES
mai 2023 - octobre 2024 (1 an et 5 mois)
Clermont-Ferrand, France
Oncology, gynecology, gastroenterology, Live Biotherapeutic Products, First-in-Human, PD, investigator-sponsored trials. Phase I, II

Set-up and organization of the Clinical Department:
o Organization of the Clinical Activities ⟶ ensure the regulatory compliance
o Request for proposals & selection for Quality Assurance & Full Package CROs
⟶ Review and negotiation of existing agreements
⟶ Request for proposals / Scopes of work and selection
o Contribution to the Quality Management System ⟶ Implementation of the clinical related Polices and SOPs

Clinical Strategy:
o Elaborate the Clinical Development Plans with the Chief Medical Officers
o Collaboration with Key Opinion Leaders
⟶ Timelines and budget planned for phases I, II and III of 8 drugs.
⟶ Target Product Profiles preparation
Clinical Management:
o Launch new clinical trials, reshape existing clinical trials
o Supervise clinical trials activities (MW, DM, Stats, Monitoring, PV, Regulatory, CMC)
o Manage trial vendors (qualification, audit, KPIs) / Full package
o Risks management (root cause identification and CAPA) ⟶ audits conducted (CROs, central labs, hospital trial site, internal)
⟶ Strong relationships with all vendors
Vendors management Early phases Définition et suivi des indicateurs (KPI) Live Biotherapeutic Products (LBP) Planification, budgétisation et prévision
Excelya on behalf of Sanofi Early Development Operations
Feasibility Manager & Global Study Manager
INDUSTRIE PHARMACEUTIQUE
juillet 2021 - mai 2023 (1 an et 10 mois)
Montpellier, France
Immunology Inflammation / First in Human / Drug-drug Interaction / PK / PD / phase I, II & III

Feasibility Manager:
o Prepare questions and forms
o Contact potential sites/investigators for clinical trials
o Evaluate / clarify answers
o Recommend trial sites to internal teams

Transversal Expert:
o Improve the feasibility processes ⟶ Harmonization procedures writing
o Develop the full outsourcing package ⟶ Scope of work preparation

Global Study Manager:
o Management of phase I, II and III clinical trials (set-up, conduct, closure)
▪ Study documents preparation and review (protocol, ICF, etc.)
▪ Regulatory dossier preparation
▪ Finance / Legal management
▪ Risks Management
▪ Specific study tools management: eCOA, questionnaires rights, pictures

Project managers coordinator:
oSupervise the Excelya’s Clinical Project Managers at Sanofi Montpellier
Full outsourcing Feasibility Vendors management Clinical Project Management
CAP Research Ltd (Mauritius)
Senior Clinical Project Manager in a trial centre / Administrative Responsible
INDUSTRIE PHARMACEUTIQUE
décembre 2013 - juin 2021 (7 ans et 6 mois)
Quatre Bornes, Maurice
Immunology, Inflammation, Metabolic, Infectious diseases, Gynecology, Vaccines, Pediatrics, Healthy Volunteers, First in patient, Pivotal, 24/7 PK, PD, PoC

Set-up of the administrative clinical department
o Preparation and implementation of the SOPs (initial and reviews)
o Creation of administrative documents templates
o Training of the staff to clinical trials, GCPs and SOPs
o Management of the clinical administrative team
⟶ Introduce pharmaceutical clinical research in a country free of clinical trials
⟶ Implement ethics and confidentiality requirements

Clinical Project Manager:
o Finance / legal activities (feasibilities, scope of work, agreements, budgets negotiation and management, invoices)
o Vendors management (tenders, assessment, oversight of activities subcontracted and deliverables, full package management (Medical Writing, Monitoring, Data Management, Statistics, Bioanalysis, etc)
o Trial Insurance management
o Study co and investigator CRAs supervision

Clinical trials management:
o Management of phase I, II and III clinical trials (set-up, conduct, closure)
* Finance / Legal management (prepare quotes, complete budget grids, review agreements)
* Study documents preparation and review (protocol, ICF, source document, site files, TMF, etc.)
* TMF Management

Regulatory referent:
o Regulatory dossiers oversight and submission
o Main contact for Health Authorities
o Liaise with Sponsors to clarify HA requests
o GDPR implementation

Quality Assurance referent:
o Preparation and implementation of the SOPs (initial and reviews)
o Risks Management / CAPA
o Audit preparation of the site
Regulatory Risks management Project Management ICH GCP Patient engagement

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Master degree
IUP Health Engineering, UFR Pharmacy
2011
Master degree
Bachelor degree
UFR Sciences
2009
Bachelor degree

Marine Cardona

Global Clinical Operations/Project Manager/Leader

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