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Amine BENIDIR

PUTEAUX

En résumé

LEADERSHIP & TEAM/PROJECT MANAGEMENT:
-Bid Defence Meetings leading
-Vendor/Client Selection/Management, Proposal analysis, discussion
-MV Reports review
-Audit/Inspection Preparation
-Project Coordination activities (Start-up, Monitoring, Data Management, CRF collection, Central Reading, IXRS, Filing, Data Base Lock, EOS) Europe & Asia
-Planning Set-up/update
-Mentorship, Coaching, Training & Work Direction of local team members, CRA/Freelance CRA, including leading of one to one/Project Meetings, acting as point of reference for operational & role-specific questions
-Conduct of Accompanied Field Visits, Authorization, Assessment visits.
-Providing of feedback on tools, processes & procedures, identification, suggestion on local & Global EMEA process improvements (i.e.: CTMS, EDC, Essential Documents, Filing, Communication, Visit Reports/Check-lists, Data Base, Templates Drafting, etc)
-Development of phoning guides (French, English), Newsletter drafting
-Collaboration with Sponsors in Business implementation, accompanied visit to meet Local identified KOLs
-Reporting of study progress to study management & Sponsor

CTMS/EDC:
-URS drafting
-Software testing, evaluation, implementation
-Vendors Selection and evaluation
-Software improvement working-group leading
-Bid defence meeting leading
-Contract negotiation
-CTMS Super-user Backup
-Point of reference between Clin Dev & IT department.
Used/Tested software: EDC (Phase Forward, RAVE, PPD), CTMS (Siebel, Clinbase, Onpoint, Medidata).


Spécialités : Feasibilities, Epidemiological, Observational, International Trials (Phase II, III, IV) in accordance with ICH-GCP, Local regulation, FDA guidelines, SOP & monitoring guidelines

-Ability to manage simultaneously several projects with different Therapeutic Areas, timelines
-Communications Skills
-Ability to learn quickly
-Dynamic, Proactive, Organized

Trainings:
Management Basics, Stress Management, Improvement on communication Skills, Audit Readiness, Team Building

Mes compétences :
CRA management
CRO
ICH-GCP
eCRF-CTMS
project coordination
SOP
FDA
Clinical trials
Startup
International
Coordinator
Industrie
Recherche
Research
Management

Entreprises

  • Teelia - Senior Consultant

    PUTEAUX 2015 - maintenant
  • EXCELYA - Senior Consultant

    Boulogne-Billancourt 2014 - 2015
  • GearDreams - Project Manager

    2013 - 2014 Project Management (Software development / Community Management)
    International Team management
  • HAYS - Clinical Project Coordinator

    Paris 2012 - 2013 International Clinical Trials (Phase III, IV)

    Coordination/CRA Management Activites
  • PPD - Senior Start-Up CRA

    2009 - 2012 Start-up Activities on International Clinical trials (Phase II, III, IV).

    Therapeutic Areas: Oncology, Cardiology and Cardio-vascular disease, Gastroenterology, Virology, Urology (Medical device), Dermatology, Nephrology, Ophthalmology, Neurology.
  • PPD France Snc - CRA

    2007 - 2009 International clinical trials (Phase II, III and IV).


    Therapeutic Areas: Oncology, Cardiology and Cardio-vascular disease, Gastroenterology, Virology, Urology (Medical device), Dermatology, Nephrology, Ophthalmology, Neurology.
  • CLINACT CRO - CRA

    2006 - 2007 Feasibilities, Epidemiological, Observational, National and
    International clinical trials (Phase III and IV).

    Therapeutic Areas: Oncology, Cardiology and Cardio-vascular disease, Gastroenterology, Virology, Urology (Medical device), Dermatology, Nephrology, Ophthalmology, Neurology.
  • Pharmacy Fellous - Pharmacy Salesman and Stock Manager

    2004 - 2005

Formations

  • International NLP

    Paris 2015 - 2015 NLP and Coaching technician Certification
  • OpenClassRoom - Tamento

    Paris 2015 - 2015 Community Manager Certification
  • Actinuum

    Paris 2015 - 2015 Certification
  • PPD (Cambridge)

    Cambridge 2007 - 2007 PPD CRA Foundation Course

    -International ethics regulation (GCP/ICH), FDA guidelines and drug safety.
    -Setting in situation of the different monitoring activities.
    -Essential documents, ISF and CRF review Specific training.
  • Clinact

    Sevres 2006 - 2006 Professional training course for CRA

    -French and international ethic regulation (GCP/ICH), drug safety, Clinical Trial requirements.
    -CRF and Monitoring Tools Drafting from a valid protocol.
    -Setting in situation and Role Playing Games of the different monitoring activities.
  • Faculté D'Alger (Alger)

    Alger 1998 - 2003 Medicine

    4 study years validation

    2003Gynecology,Orthopedics,Rheumatology,Functional rehabilitation,Endocrinology,Urology,Psychiatrics
    2002Gastroenterology,Oncology,Hematology,Pediatrics,Infectious disease
    2001Neurology,Cardiology,Pneumologia
    2000Internal medicine,Radiology,Pharmacolog