Naouel BOUAFIA
Associate Clinical Trial Manager
Paris
Profil professionnel
Clinical Manager with solid local and international experience in clinical project management, capable of overseeing every stage of a clinical study—from managing investigative sites, clinical data, and monitoring activities to coordinating large research teams, ensuring compliance with procedures and regulatory documentation, and managing the overall study budget.
Vue d'ensemble
2
2
Languages
1
1
Certification
10
10
years of post-secondary education
14
14
years of professional experience
Expérience
Consultant
Freelance
2025.11 - 2026.06
Clinical Project Manager
INSERM
, France
2022.05 - 2025.05
- Management, writing and participation in writing of the protocol, protocol amendments, patient documents, SOPs of the European clinical trial 'TREOCAPA'.
- Medical and regulatory documents writing and translating, CAPA plan and risk assessment documents writing in response to a European inspection institution involved in the European trial TREOCAPA.
- Coordination of the local study team and the European management team: more than 15 project managers, 20 monitors and more than 200 investigators involved in 15 countries.
- Sites management from selection to close-out including regular management of monitoring and data cleaning.
- Contracts negotiation and amendments.
- Budget management.
- Regular reporting on the study progress to the european sponsor.
- The TREOCAPA study is a phase II and III, randomized, double blind, European multicenter study with two phases comparing early prophylactic treatment by Acetaminophen to placebo in extremely preterm infants (two groups: 23-26 weeks and 27-28 weeks of gestation), performed in 43 investigational sites of 15 European countries.
- Démonstration d'un sens du leadership en gérant des projets de la conception à la livraison.
Freelance Medical Writer
Indépendant
2021.02 - 2022.12
Clinical Operations Project Manager
Kayentis
Grenoble, France
2021.04 - 2021.09
- Managing Clinical studies during their running and closing phases.
- Assist clinical investigation sites at start-up.
- Proactive monitoring of sites during the clinical study.
- Coordination between the customer and internal teams.
- Interaction with the outsourced Helpdesk.
Co-investigator intern
Beaujon Hospital
Paris, France
2020.01 - 2020.05
- Establishment of a prospective single-center observational study, to evaluate complications in patients with parenteral nutrition.
- Analysis of patients' medical files.
- Collection of their clinical and biological data.
- Screening and inclusion of patients.
- Definition of clinical and biological characteristics of patients.
- Analysis and discussion of the results.
- Writing the end of study thesis.
Intern Researcher
Laboratory of Microbiological Engineering
Constantine
2019.01 - 2019.06
General Practitioner
Medico Diagnostic Centers
Algiers
2012.12 - 2018.06
Formation
Master 2 - Nutrition Sciences
University of Constantine
2018.09 - 2019.06
Research Master 2 - Clinical research methodology and quantitative methods
Sorbonne University
France 2020.10 - 2021.06
Master 2 - Nutrition & Health
Rennes 1 University
France 2019.09 - 2020.09
Doctorat - physician
Constantine Faculty of Medecine
Algeria 2004.01 - 2011.12
Compétences
Effective time management to complete tasks within deadlines
Rapid and efficient execution of tasks
Quick adaptation to different people and situations
Handling emergency situations with calm and composure
Effective teamwork
Certificats
English CLES B2 certification 2020
Category B driving licence
ENI Certification - Excel
Publications
- Prophylactic Treatment of Patent Ductus Arteriosus With Acetaminophen: A Randomized Clinical Trial., 2026-04-01, jamapediatrics, 10.1001/jamapediatrics.2025.6150
- Experience and lessons learned relating to investigational product supply in the design and delivery of a paediatric investigator-initiated clinical trial., 2025-06-01, Contemp Clin Trials Commun, 10.1016/j.conctc.2025.101517
- Cite TREOCAPA: prophylactic treatment of the ductus arteriosus in preterm infants by acetaminophen-statistical analysis plan for the randomized phase III group sequential trial., 2025-02-01, Trials, 10.1186/s13063-025-08751-8
Informations complémentaires
- Reading
- Travel
- Passion for swimming
Langues
Anglais
Bilingue
Français
Langue maternelle
Chronologie
Consultant
Freelance
2025.11 - 2026.06
Clinical Project Manager
INSERM
2022.05 - 2025.05
Clinical Operations Project Manager
Kayentis
2021.04 - 2021.09
Freelance Medical Writer
Indépendant
2021.02 - 2022.12
Research Master 2 - Clinical research methodology and quantitative methods
Sorbonne University
2020.10 - 2021.06
Co-investigator intern
Beaujon Hospital
2020.01 - 2020.05
Master 2 - Nutrition & Health
Rennes 1 University
2019.09 - 2020.09
Intern Researcher
Laboratory of Microbiological Engineering
2019.01 - 2019.06
Master 2 - Nutrition Sciences
University of Constantine
2018.09 - 2019.06
General Practitioner
Medico Diagnostic Centers
2012.12 - 2018.06
Doctorat - physician
Constantine Faculty of Medecine
2004.01 - 2011.12