Herve FOUCHE

En résumé

Entreprises

• Oracle - Principal Solution Consulting (Clinical R&D)

  Colombes 2008 - maintenant Subject Matter Expert in Clinical R&D - Operations & IT Integration.

• Bearing Point - Life Sciences Consulting Practice

  Paris la Défense cedex 2008 - 2008

• IBM Global Business Services / Life Sciences - Managing Consultant

  2007 - 2007 * Securization & roll-out of high-level integration projects for Life Sciences clients (pharma, biotech). Build of Functional Requirement Specifications. Elaboration of contracts & related operating budgets. Alignment of internal organizations over project(s) management and delivery.
  
  Management: Miscellaneous go-and-get teams
  Budget: Ad hoc (per client)
  Accomplishments: Differentiated engagements. Client satisfaction.

• Sanofi Pasteur - Head Integration Clinical Systems / CDM

  Lyon 1996 - 2006 * Management & deployment of transversal Information System (IS) solutions/applications: Electronic Data Capture (EDC) – CRFs Imaging & Indexing – Business Intelligence portal – Data Warehouse.
  * Lead of vaccines development Clinical Data Management operations [budget, internal staff, CROs, technical DBA standards, encoding dictionaries (MedDRA, WHO-DRL), SOPs & trainings etc …].
  * Qualification and full deployment of a central Clinical Data Management System (i.e. Clintrial v#4) across four sites [i.e. 2 CDM sites in France & 2 CDM sites in North America (USA + Canada)].
  
  Management: Average of 15 staff in Europe
  Budget: Range of 2 M€ per annum
  Accomplishments: Global standardized CDM operations. Substantial efficiency gains. Integrated R&D IT solutions

• Medpass International - Director Clinical Operations

  1995 - 1996 * Implementation of clinical trials dedicated to the medical devices industry: elaboration / review of technical protocols, implementation of clinical sites (hospitals), data collection and processing.…
  
  Management: Miscellaneous go-and-get teams
  Budget: Ad hoc (per client)
  Accomplishments: Regulatory dossiers.

• Wyeth Ayerst Research - Head Clinical Data Management (CDM)

  1989 - 1995 * Set-up & direction of a local CDM department in charge of editing and processing clinical (drug) trial data, Phase I to Phase IV, whether from European or international studies.
  * Leader or member of committees overlooking development plans, clinical protocols design and review, standard Case Report Form (CRFs) and optical imaging / clinical documents workflow applications.
  
  Management: Average of 15 staff (Europe)
  Budget: Range of 1 M€ per annum
  Accomplishments: Centralized / Locked clinical databases (on time, within budget). Outstanding efficiency & quality benchmarks.

• Smith Kline & French - Head Clinical Data Management (CDM)

  1985 - 1989 * Set-up & direction of a local CDM department in charge of editing and processing Phase III clinical (drug) trial data as well as related pharmacovigilance records [i.e. adverse drug reactions (ADRs)].
  * Installation and maintenance of the related software, hardware and network.
  
  Management: Average of 6 staff (Southern Europe)
  Budget: Not Applicable
  Accomplishments: Clinical databases (on time, within budget). Management of Safety.

Formations

• Essec

  Paris La Défense 1992 - 1993 International Management Development (IMD)

• Université Paris 6 Pierre Et Marie Curie

  Paris 1986 - 1987 Statistical methods & techniques relevant to Clinical Research

• Université Paris 11 Paris Sud

  Orsay 1983 - 1984 Computer Science

• Université Paris 11 Paris Sud (Chatenay Malabry)

  Chatenay Malabry 1979 - 1983 Thesis in toxicology (Aflatoxins)

• Université Paris 11 Paris Sud

  Orsay 1973 - 1977 Biochemistry

Réseau

• Mahnaz BLONDEL

• Marianne BERNY

• Marie Paule RICHARD

• Thierry LAMBERT