Christine COTTO

En résumé

Entreprises

• Allergan - Regional Area Manager

  Courbevoie 2013 - 2014 -Management of a virtual team with 9 out sourced Monitors and 3 Lead CRAs (FSP Model). ;
  -Mentoring and support for new Team members (CRA, CPA, Lead CRA), Transition Plan process for Study CRA Handover.
  -Collaborating with International Project Manager for studies staffing and study quality oversight.
  -Collaborative work with Team management (CRO manager and Project Manager) for candidate interview, performance evaluation.
  -Oversight of the quality by Visit Report Review (VRR) and on site Quality Assessment Visit (QAV) to evaluate CRA performance and identify CRA training needs
  -Guaranty of audit readiness insuring Central File maintenance process continuously up to date and providing support for audit preparation,
  -Primary contact with Allergan France and Allergan UK regulatory department in the field of Monitoring, Reference for regulatory procedure as CNIL or CNOM submissions.
  -Reviewer and Facilitator for European and local CRA Meetings
  -Participation in initiatives, i.e. SOP review, tools/Forms creations.
  -Flexible working in different therapeutic areas: Ophthalmology, Urology, Dermatology, Neurology, Aesthetics and Medical devices.

• Allergan - Principal clinical Research associate

  Courbevoie 2011 - 2013 * All Monitoring activities from site selection to close out visit, including boosting visit and audit preparation visit in several therapeutic Area as Ophthalmology, Urology, Aesthetic and Medical device.
  * Rapid response for Site Assessment visit, Quality Assessment visit and audit preparation in several European sites (Check republic, Poland, Belgium, Italy)
  * Training and support for new team personnel. ;
  * Primary contact with Allergan France, Reference for regulatory procedure

• Quintiles - Clinical Team Lead

  Durham 2009 - 2011 * Ethic Committee submission : preparation of the study file for CPP submission ;
  * Translation and adaptation of patient documents as informed consent form and advertising documents for French requirements.
  * French Specific regulatory instance communication as : CNIL and CCTIRS, CNOM, ANSM
  * Contract negotiation with Hospital direction and Investigators

• Quintiles - Principal clinical Research associate

  Durham 2007 - 2009 * Investigational site selections for more than 37 phase II and III clinical studies in oncology, haematology, gastroenterology, MICI (Crohn disease, ulcerative colitis), psychiatry and neurology.
  * Mentoring for junior CRA.

• Quintiles - Senior clinical Research associate

  Durham 2005 - 2007 Monitoring of 14 clinical studies in phase II and III (from initiation to close out visit) : cancer, haematology, gastroenterology,

• Merck KGaA - Clinical Study Leader

  Darmstadt 2001 - 2004 In charge of implementation and Monitoring in France for international studies (Phase II and III) in diabetes, dyslipidemia, atherosclerosis and oncology.

• ELA Recherche - Clinical trial Coordinator

  2000 - 2001 ELA Recherche - Sanofi-Synthélabo (pharmaceutical company) - Le Plessis Robinson:
  
  * Monitoring Activities for Medical Device studies in order to obtain the EC Mark.
  * Coordination of 6 international trials (phase I to II in Medical Device) regarding pace makers and catheters,
  * Coordination of a national trial concerning a pace maker study (Phase II): 5 investigator sites.

• Servier - Clinical study leader

  Suresnes 1999 - 2000 Implementation and Conduct of a clinical study in tinnitus disease (phase IIIb): Managing Ethic Committee submission and Monitoring : 28 investigator sites from selection to close out visit.

• Société LAB-AAI - Clinical Research associate & Junior Clinical team leader

  1997 - 1999 * Junior Clinical team leader coordinating a national phase IV trial regarding vitamin D during pregnancy: coordination of 2 CRAs managing 4 sites.
  * Conduct Monitoring for Trials in cardiology (phase IV): 24 investigator sites in France.
  * Conduct Monitoring for Trials in obesity and hypercholesterolemia (phase IV): 15 investigator sites in France.

Formations

• Université Paris-Sud 11

  Chatenay Malabry 2001 - 2002 Master
  
  DESS (Master II) du Droit de la Santé ( Public Health Right)

• Université Pierre Et Marie Curie (Paris VI)

  Paris 1999 - 2000 DU de nutrition du sportif - AF CREFF

• Université Paris VII Jussieu

  Paris 1999 - 2000 DIU CESAM
  
  DIU CESAM option STARC (Statistique en Recherche Clinique, Méthodes et Pratique)
  Centre d'enseignement de la statistique appliquée à la médecine et à la biologie médicale

• Université Paris VII Jussieu

  Paris 1998 - 1999 DIU CESAM option SPEC
  
  DIU CESAM option SPEC (Théorie et pratique des Essais cliniques)

• CHU Nice Sophia Antipolis - Faculté De Medecine

  Nice 1990 - 1996

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