Dorothee CHEKROUN

En résumé

Entreprises

• Johnson &Johnson - Study Manager

  New Brunswick 2014 - 2015 * Ensure that trainings are performed appropriately and in a timely manner ;
  * Work in compliance with the SOPs and the ICH ;
  * Participate to the Quality System improvement
  
  * Clinical plan development ;
  * Design the clinical plan in collaboration with Medical & Clinical Affairs team (including resources and timing). ;
  * Manage the realization of the study either by a CRO or by an investigator internally. Ensure the documentation is compliant with the SOPs, ICH and has been approved accordingly. ;
  * Collect results and all the documents of the study (final report) ;
  * Check the synthesis of the study and ensure the communication to concerned people.
  
  * Management of current in vivo and in vitro tests ;
  * Place studies internally or with CRO ;
  * Manage the study: this includes protocols redaction or review, IP order, follow-up, results review, redaction memos/reports...
  
  -Write claim support and complete fact book with the appropriate documentation

• L'OREAL Innovation - Study Manager

  2012 - 2014 Coordination, Monitoring and Implementation of Clinical Trials, in collaboration with the Centre Sabouraud specialized in dermatology (hair and seed coat)
  * Development and redaction of regulatory documents to be submitted to CPP and ANSM (AC) ;
  * Writing investigators brochures for submission to authorities (ANSM and CPP) ;
  * Participate in the preparation of clinical study reports ;
  * Provide scientific and administrative monitoring of voluntary patient records (CRF and DM) ;
  * Ensure compliance with the SOPs ;
  * Monitoring and reporting of data and the monitoring of the investigational site activities ;

• Inserm - Coordination Clinical Trial Ophalmology

  PARIS 13 2011 - 2012 Coordination Clinical Test - INSERM, Ophthalmology
  * Redaction and validation of study materials: investigator's brochure, protocol, CRF, Notices ;
  * Preparation, writing and submission of regulatory documents to the Competent Authorities (CAs) ;
  * Implementation of the quality system and procedures in agreement with Good Clinical Practices ;
  * Participate in meetings of feasibility and implementation of tests ;
  * Management of schedules and budgets and switching investigator sites ;
  * Monitoring and control of patient recruitment (pre-inclusion and inclusion) ;

Formations

• IMVI

  Paris 2010 - 2011 Master 2
  
  : « Développement des Produits de Sant頻 - University Paris 7

• IMVI

  Paris 2009 - 2010 Master 1
  
  Specialized in Immunology - University Paris 7 (Denis Diderot)

Réseau

• Celine BARBIRA

• Chekroun DOROTHÉE

• Jacques LINARES

• Nicolas LEGRAND

• Nina GAL

• Pécory Alhassane COULIBALY

• Sarah GHNASSIA

• Valerie MEDLOCK-BELJEAN

• Veronique CONTER