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Corinne MARTINELLA

Élancourt

En résumé

Results Orientation & Initiative, Problem Solving skills, Engaged, Good Teaching Capabilities, Strong Interpersonal Relationships, Customer Focus, Hard Worker.

Mes compétences :
Dispositifs médicaux
Oncologie
Recherche
Recherche clinique
responsable de projet
Medical Devices
GCP
Clinical Trials
Tumor
Hernia
Oncology
Risk Management
Risk Analysis
Monitoring
Bariatic
Project Scheduling
Product Development
Problem Solving
Phase II Clinical Trials
Microsoft Word
Microsoft Project
Microsoft PowerPoint
Microsoft Excel
Microsoft Access
Gastroenterology
GCP training
French Law
FileMaker Pro for Windows
Data analysis
Clinical investigation design
Clinical Research
Case Report Forms
CRO CRAs coordination
Bronchiolitis
Audit
Advanced Clinical Project Management
Adobe Photoshop

Entreprises

  • Covidien

    Élancourt maintenant

  • Medtronic - International Clinical Project Manager

    Boulogne-Billancourt 2009 - maintenant 1 - Post market studies management in US, UK, Sweden, Denmark, Belgium, The Netherlands, Italy, Germany.
    Clinical investigation design, clinical investigation budget, generation of study documents (protocol, informed consent forms and case report forms), bibliography and preparation of regulatory documents (submission to Ethics Committees) in accordance with GCP, ISO 14155 standards and Medical Device Directive (93/42/EEC).
    Investigator meeting organization, selection, initiation / monitoring visits & SDV in Europe, conference call participation (US / Europe) and CRO CRAs coordination. Data analysis and preparation of clinical reports. Supervisory responsibilities. Assist investigators in preparation of publications.

    2 - Clinical expertise provided for new product development projects / collaboration with Marketing, Regulatory Affairs, Medical Affairs, Quality Affairs and R&D in the following fields : Bariatric, Hernia, Oncology …
    - Literature review, Medical Affairs strategy and Redaction of clinical evaluation for CE mark
    - Review of IFU and Risk analysis
    - Answers to FDA on clinical-related topics and participation to audits (directive 1993/42/CEE ; 2007/47/CEE ; ISO 14155)

    3 - Participation to workgroups: Global clinical procedures (Europe / US), a weekly review
    Syndicat National des Industries et des Technologies Médicales (SNITEM)
    Safety Working group (Procedures, Work, Instructions, Training etc…)
    Implementation of a KOL program

  • Quintiles - Clinical Research Associate - oncology - homebased

    Durham 2006 - 2009 Phase II studies with central laboratory and central radiology in medulloblastoma and high grade glioma in children and Ewing’s Sarcoma family of Tumors (Children/ adults).
    Phase III studies with central laboratory and central radiology in renal carcinomas, breast cancer, pancreatic tumors, lung cancer.
    Attendance to invest meetings, delivery of GCP training’s, site selection visits, initiation visits, monitoring visits & SDV in France, query resolution (CRF, central lab and central radiology), drug accountability, management of SAEs, collection of regulatory packages, re-labelling process…

  • Hospices Civils de Lyon - FRANCE - Scientist Associate

    2005 - 2006 Responsible for monitoring multi-protocol clinical trials in France (Gastroenterology / Obstetrical Practice / new born bronchiolitis), assure adherence to Good Clinical Practices, investigator integrity and compliance with all study procedures. Writing trial protocols, patient information sheets and consent forms; presenting trial protocol to an ethics committee; managing regulatory authority applications and approvals; designing CRFs.

  • Monitoring Force France - Clinical Research Associate

    2004 - 2004 Phase 4 in-patient Cardiovascular Study:
    - Pre-study site visits and site initiation. ;
    - Management of regulatory documents and financial convention required for the site initiation.

  • Beaufour Ipsen - Paris FRANCE - Clinical Research Associate

    2004 - 2005 Phase 3b in-patient neurology Study:
    To assure adherence to Good Clinical Practices, investigator integrity and compliance with all study procedures, the protocol, applicable regulatory requirements and Good Clinical Practice: monitoring visits & SDV in France, query resolution, drug accountability, management of SAEs and management of master file documents.

  • Unité INSERM - Research Associate

    1996 - 2003 Advisor: Dr. Edith PUCHELLE: Differential expression of matrix metalloproteinases and IL-8 during regeneration of human airway epithelium in vivo.
    Advisor: Dr. Myriam POLETTE: Regulation of tumour invasion and MMPs expression by the 3(IV) chain of type IV collagen.

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