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Malt Strategy
Marine CardonaMC

Marine Cardona

Global Clinical Operations/Project Manager/Leader

€750/day
Montpellier, FR
8-15 years
Full outsourcing
Vendors management
Patient-centered
Early phases
Agile Mindset

Average response time: 1 hour

About Marine

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.
Biotechnologies
Pharmaceuticals

  • French

    Native or bilingual

  • English

    Fluent

Can work on-site
Montpellier (up to 50km)

Experience

  • Nexbiome Therapeutics
    Clinical Development Head / Senior Clinical Project Manager
    BIOTECH
    May 2023 - October 2024 (1 year and 5 months)
    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
    PHARMACEUTICALS INDUSTRY
    July 2021 - May 2023 (1 year and 10 months)
    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
    PHARMACEUTICALS INDUSTRY
    December 2013 - June 2021 (7 years and 6 months)
    Quatre Bornes, Mauritius
    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
Check out Marine's experience

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Education

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

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