Freelancer profile translated to English.

Description

Need a one-time or long-term resource? Passionate about clinical trials and a true all-rounder, I enjoy coordinating projects and leveraging my experience to help companies facilitate clinical trials for investigators and patients. My goal: to contribute to the development of innovative therapies to cure or improve the health and well-being of patients.

Industry field of expertise

Languages

French
Native or bilingual
English
Fluent

Workplace preferences

Can work on-site

Montpellier (up to 50km)

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 Definition and monitoring of indicators (KPI) Live Biotherapeutic Products (LBP) Planning, budgeting and forecasting
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

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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

About Marine

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