Sophie MARCHAND

En résumé

Entreprises

• Freelance - Freelance Consultant in Clinical Operations

  2016 - maintenant Start-up activities: Feasibility, selection, budget/contract negotiation
  Regulatory activities: EC, CA, National Medical Council, CNIL submissions
  Monitoring activities: Feasibility, Site qualification/ initiation/ monitoring/ close-out visits
  Site coordination activities: CRF completion
  Management activities: CRA team (Lead CRA) & Clinical Project Management (CPM)

• Transgene S.A., Illkirch, France - Clinical Trial Manager

  2010 - 2015 Clinical development of an immunotherapeutic product In Lung Cancer:
  • Primary contact for functional area representatives in managing all aspects of protocol execution ;
  • Providing input for the development of study documents including protocol, informed consent form, CRF and procedure manuals ;
  • Selection and management of external vendors and participation to budget negotiation and contract establishment ;
  • Selection of the sites and countries participating to the studies ;
  • Coordination and assistance in the planning of regulatory activities ;
  • Conduct of site visits for internal studies and co-visits with vendors for outsourced studies ;
  • Maintenance of relationships and monitoring of vendors performance ; management of the scope of work and study progress ;
  • Development and management of comprehensive study timelines and metrics ;
  • Management of study budget including validation of clinical invoices against approved budget ;
  • Management and forecasting of clinical trial material ;
  • Review of site visit reports issued by the vendors to ensure quality and resolution of site-related issues ;
  • Provides study-specific training and leadership to vendors, CRAs, sites and trainees.

• Kendle International, Paris, France - CRA / Coordinator - CRO and Laboratory environments - Oncology

  2006 - 2010 1- Coordination activities :
  Phase IIb International study in Lung Cancer:
  • Management of project team (12 CRAs involved in 7 countries);
  • Coordination of all monitoring and close-out activities and communication of the status of these activities to the Project Leader and Sponsor;
  • Conduct of co-monitoring visits with project team;
  • Review of site visits reports;
  • Follow-up of study budget (direct & indirect costs).
  
  2- Monitoring activities :
  Phase II/IIb studies in Lung and Breast Cancer (outsourced at ROCHE laboratory since May 2009):
  • Preparation of submission files to Health Authorities, Ethics Committees and Medical National Council;
  • Conduct of site monitoring and close-out visits (Source Data Verification, resolution of data queries, SAEs notifications, study file archiving);
  • Ensurance that the investigators and other study staff at sites are aware of and comply with the study protocol, procedures and with ICH/GCP and other regulatory requirements; site training provided as required in order to meet study requirements;
  • Maintainance of regular communication with sites and reporting of all site visits and other contacts on a timely basis;
  • Maintenance of study TMF;
  • Follow-up of investigator and overcosts payments;
  • Skilled in site Audit.
  
  3- CRA Training and Assessment activities for Outsourcing Department.

• Institut Gustave Roussy, European Center for Cancer Disease, Villejuif, France - CRA - Hospital environment - Oncology

  2005 - 2006 Immunotherapy Department - Dr. B. ESCUDIER
  
  Management of Phase I, II and III studies in Oncology (Senology, Pneumology, Gastrology, Gynecology and Urology):
  • Training of study staff (nurse, laboratory and radiology staff);
  • CRFs filling, resolutions of queries and SAEs notifications;
  • Management of specific samplings;
  • Skilled in Audit and FDA inspection.

• Institut Jacques Monod, Paris, France - Doctorate & Post-Doctorate - Neurosciences

  1998 - 2003 Laboratory “Biology of Membranes” Dr J. CARTAUD, in collaboration with Prof. J-P CHANGEUX Laboratory at Institute Pasteur (Paris, France) and the Center for Neuromuscular Disease (Faculty de Medicine, Ottawa, Canada).
  
  Management of 2 projects on the Neuromuscular Junction:
  • Expertise in Cellular Biology, Molecular Biology and Biochemistry;
  • Writing and Publications of international scientific articles and reviews;
  • Written paper and verbal communication for national and international meetings;
  • Training of 5 students.

Formations

• Université Paris 6 Pierre Et Marie Curie

  Paris 1998 - 2002 Neurosciences

• Ecole Normale Supérieure

  Paris 1995 - 1998 Biologie et Biochimie

Réseau

• Agne JASAITIENE

• Guillaume BERTIN

• Maud REGNIER

• Pascal JAY

• Patrick AGUIE

• Sandrine DELMAS

• Serene BOOKER

• Sylvie LEBEAU EYCHENNE

• Tony GONCALVES

• Yvain ROBREAU