Harold COUCHOUX

En résumé

Entreprises

• Alizé Pharma - Clinical Development Manager

  2017 - maintenant * Elaboration of the global development strategy of medicinal products ;
  * Supervision of the elaboration of the scientific rationale and clinical study design ;
  * Study documents (Protocol, IB, Informed consents) writing ;
  * Selection, management of external vendors (CRO, eProviders, CMO)

• Medpace - Senior et Lead Coordinateur Soumissions Réglementaires, Study start-up

  2013 - 2017 - Site management;
  - Investigator/hospital/association clinical study agreements, submission to medical board (CNOM);
  - Informed consent form review and approval
  - Regulatory document collection, review and transmittal approval
  - Adherence to project timelines & expectations
  - Coordination of all Competent Authority and Ethics Committee (EC) tasks required for site IP approval in accordance with local regulations, ICH Guidelines.

• Medpace - Senior and Lead Study Start-up Coordinator

  2013 - 2017 * Coordination of start-up activities in France and Europe ;
  * Regulatory Submissions to Ethics Committees (EC) and Regulatory
  Authorities (RA)
  * Primary contact with sites, CRAs, Sponsors and external vendors (CROs)

• TBF Tissue Engineering - Clinical Project Manager

  Mions 2010 - 2013 Management of 2 Phase III (Advanced Therapy Medicinal Product) + 2 phase II (tissue) trials in France and abroad
  - Monitoring: Europe/France: assure compliance of collected data with all protocol requirements
  Trainings: Site initiations in France and abroad
  - Regulatory documentation: Assure compliance with State regulations, ICH/GCP guidelines and SOPs
  - Regulatory submissions to Ethics Committees and Regulatory Authorities
  - Implementation of study-related documentation (TMF, e-CRF)
  Data handling: Assure timely and accurate completion of Data Clarification Forms (DCFs)/Queries
  Reports: Completion and submission of visit reports according to SOP requirements.
  Maintenance of awareness of key study performance indicators for own sites (patient enrollment)
  Safety reporting to EC, Competent authorities, EudraVigilance WEB (EVWEB)
  Documentation and tracking of the resolution of all site-specific protocol-related issues from visit to visit
  
  Contact and coordinating person for a Japanese Biotechnology company
  Validation of feasibility of a phase II clinical trial (over 15 countries):
  - Communications: privileged contact person for a German CRO and a Japanese Biotech company
  - Logistics: in charge of organizing all logistics aspects (transports, timelines...) and validating study documentation in collaboration with CROs for an Phase II Clinical Study.

• Emory University - Postdoctoral Research Fellow

  Thiers 2008 - 2010 * Research in inner ear physiology

• Emory and Iowa City Universities, Physiology and Pharmacology Departments - Post doctorant

  2008 - 2010 Postdoctoral fellow, Science Project: study of proteins involved in calcium homeostasis of the inner ear, Ear Physiology
  Biology of the inner Ear training in Marine Biological Laboratory, Woods Hole, MA, USA

• Claude Bernard University - PhD Student & Teacher

  2003 - 2008 * Research in skeletal muscle physiology
  
  * Taught BSc and MBSc students about general physiology (cardiac, muscle, GI tract) and cellular and
  molecular biology ,

Formations

• SupSanté Institute

  Lyon 2010 - 2010 Clinical Research Associate Certificate

• Institut Préparatoire Sup-Santé

  Lyon 2010 - 2010

• Université Claude Bernard Lyon 1

  Villeurbanne 2005 - 2006 Use certifications
  
  * Level 1 Biological Experimentation and Professional English in
  Computer/Other Skills
  
  
  * Microsoft Office Suite
  
  * EudraCT Vigilance safety reporting system
  * Languages:

• Université Lyon 1 Claude Bernard

  Villeurbanne 2003 - 2007 Physiologie moléculaire et cellulaire
  
  - Research in skeletal muscle physiology, protein interactions, molecular and cellular physiology
  - Taught BSc and MBSc students about general physiology (cardiac, muscle, GI tract) and cellular and
  molecular biology

• Université Lyon 1 Claude Bernard UCBL

  Villeurbanne 2002 - 2003

• Université Lyon 1 Claude Bernard

  Villeurbanne 2001 - 2002

• Lycée Gabriel Voisin

  Tournus 1995 - 1998 Scientifique