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Christine COTTO

Courbevoie

En résumé

18 years of experience in Clinical trial field encompassing all phases of drug development with strong knowledge of the European regulatory specificity and covering many different indications in ophthalmology, metabolic diseases, oncology, Cardiology, urology, haematology, psychiatry, surgery and Medical Device.
Professional, well organized and passionate
I am a good listener always focused on problem solving, quality maintenance and goal achievement.

Available immediately and open to new opportunities for my professional carrier, I will be pleased to discuss about my experience to verify if my competencies could match with your expectation and the needs of your company.

Mes compétences :
Oncology
Site selection
Audit preparation
Team Management
Phase IV Clinical Trials
Microsoft Word
Microsoft PowerPoint
Microsoft Excel
Microsoft Access
Medical Devices
Informed Consent
Conduct Monitoring
Clinical Experience
Cardiology

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

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