Stéphanie MOUSSET

En résumé

Entreprises

• PRA Health Sciences - Clinical Team Manager III

  2014 - maintenant

• ICON plc - International Clinical Trial Manager Level 2

  2012 - 2014 Functional lead accountable for the execution and delivery of clinical operations activities in EU countries
  • Monitoring the trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems.
  • Manage study communication and issue escalation within the EU team
  • Understand the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conforming to those requirements. Oversight of submission process to regulatory and/or ethic committee
  • Management and maintenance of the trial budget(s).
  • Define and ensure appropriate resource requirements.
  • Input on or establishment of procedures or study documents to ensure adherence to protocol and other requirements (like ICH GCP, or SOPs).
  • Accountable for creation, maintenance and oversight of EU TMF all trial files.
  • Provision of regular and ad hoc information, both written and verbal, to all the trial participants / sponsors. Study performance reporting to upper management.
  • Leading protocol deviation review and follow-up task at study level (all regions, including meetings with sponsor).
  • Vendor management: preparation of scope of work, vendor oversight, and assessment.
  • Involvement in inspection and audit answer reports.

• ICON plc - Lead CRA acting as PM

  2009 - 2012

• ICON Clinical Research - CRA

  2007 - 2009

• ICTA PM - CRA

  CHALAIS 2002 - 2007

Formations

Réseau

• Anne-Aurore PAIREL

• Carole DUNYACH

• Duchesse KALA-KALA

• Gerda QUENUM

• Maud REGNIER

• Mina LOUAHDI

• Olivier PETIT

• Ondine TROALEN

• Stanislas KRASENSKY

• Stephane BOUDAUD