Freelancer profile translated to English.
Back to original languageAbout Nacim
Experienced professional in clinical research and medical operations management. With several years of experience as a general practitioner and operating room coordinator, I have acquired in-depth expertise in clinical research project management, regulatory compliance, and clinical trial coordination.
Key Skills
Project Management: Planning, organization, and supervision of clinical research projects, with a demonstrated ability to lead studies from start to finish.
Regulatory Compliance: Solid knowledge of Good Clinical Practices (GCP), GDPR, and the requirements of ethics committees and health authorities (ANSM, CNIL).
Clinical Trial Coordination: Expertise in managing studies in various medical fields, including surgery, medical devices, drugs, anesthesia, and nursing care.
Communication and Collaboration: Proven communication skills with research teams, investigators, and partners, fostering effective collaboration and optimal results.
Use of Health Technologies: Experience with clinical data management tools (eCRF, CTMS, ePRO) and statistical analysis software to ensure study accuracy and efficiency.
Professional Experience
Operating Room Coordinator: Supervision of surgical operations, management of schedules and resources, ensuring quality and safety of care, and resolving operational issues.
Clinical Research Project Manager: Founder of a clinical research project management company, responsible for study design and methodology, protocol writing, ethics committee submissions, and study monitoring until closure.
French
Native or bilingual
English
Fluent
Spanish
Native or bilingual
Can work on-site
Toulouse (up to 50km)
Experience
- INSERMClinical Research Project ManagerPUBLIC SECTORAugust 2024 - Today (1 year and 10 months)Physician | Clinical Research Project Manager | Freelance ConsultantSpecializing in clinical research project management, I assist you in coordinating your studies, scientific writing, and data analysis. With dual expertise in medicine and clinical trial management, I ensure regulatory compliance (ICH-GCP) and process optimization to guarantee reliable and actionable results.My Services:✔ Clinical trial management and coordination✔ Scientific writing (protocols, reports, publications)✔ Regulatory compliance and document management✔ Data extraction and analysis (Python)
- ELSANClinical Research Project ManagerMEDICALDecember 2023 - Today (2 years and 6 months)Paris, FranceManagement and coordination of clinical studies, from design, budgeting, selection of centers and Investigators, resource allocation, submission to ANSM, CPP, CNIL, translation of protocol to English for registration on Clinicaltrail.org, writing ICF, development of investigator binder, Investigator Brochure, SOPs, writing agreements, coordination of 15 centers, Implementation, CRF design, eCRF and ePRO, monitoring of inclusions, monitoring, tracking on CTMS, KPI, monitoring report, corrective actions, center closure, writing final report and medical article for publication.
- SFHGClinical Research Project ManagerMEDICALDecember 2023 - Today (2 years and 6 months)Paris, FranceManagement and coordination of clinical studies, from design, budgeting, selection of centers and Investigators, resource allocation, submission to ANSM, CPP, CNIL, translation of protocol to English for registration on Clinicaltrail.org, writing ICF, development of investigator binder, Investigator Brochure, SOPs, writing agreements, coordination of 15 centers, Implementation, CRF design, eCRF and ePRO, monitoring of inclusions, monitoring, tracking on CTMS, KPI, monitoring report, corrective actions, center closure, writing final report and medical article for publication.
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Education
- Doctor of MedicineINESM2007Doctorat en médecine
- DIU Clinical Research Project ManagerFaculty of Medicine Descartes, Paris2024Conception et Méthodologie des Études Cliniques : Apprentissage des principes de base de la conception des études, des protocoles de recherche, et des méthodologies statistiques. Réglementation et Éthique : Formation sur les aspects éthiques et réglementaires de la recherche clinique, y compris la soumission aux comités d'éthique (CPP), aux autorités de santé (ANSM) et à la CNIL. Gestion de Projet : Techniques de gestion de projet appliquées à la recherche clinique, y compris la planification, le suivi des progrès, et la gestion des risques. Communication et Coordination : Développement de compétences en communication pour travailler efficacement avec les équipes de recherche, les investigateurs, et les sponsors. Outils et Logiciels : Formation à l'utilisation des principaux outils et logiciels de gestion des données cliniques (eCRF, CTMS, ePRO) et de suivi des projets