
Stefania Bordin
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About me
Since March 2020 Parexel International _ Senior Start Up
Education

EF
-Foreign Languages Courses Summer courses of foreing languages for high school studentsActivities and Societies: several travels abroad for foreing languages courses and job stages Intensive courses of English in London and of French - Paris and Cannes. Every day lessons and contacts with foreign students abroad.

Liceo linguistico sperimentale scientifico
1992 - 1997Lingue studiate: inglese, francese e spagnolo Diploma liceo linguistico 54/60Foreign languages: French, Spanish and English. Scientific matters: mathematics, biology, chemistry, physics. History Latin and arts.

Libera Università di Lingue e Comunicazione IULM
1997 - 2001Laurea / Degree Lingue e Letterature Straniere / Foreign languages and literatures 104/110Activities and Societies: Gruppo di dibattito Laurea in inglese, seconda lingua spagnolo / Degree in English, second Language SpanishAltri esami: Psicologia, Cinema, Storia dell'arte / Other exams: Psycology, Cinema, Art History
Experience

Globe translation
Mar 2002 - May 2002TranslatorTranslations of official documents: certificates of residence, marriage, birth and contracts into English, Spanish and French sworn certified translations

Engelhard Corporation
Sept 2003 - Oct 2004Sales DepartmentBusiness development (France - Italy - Switzerland - Germany) - Lotus Notes - Product Technical Data Sheets and contracts translations Commercial offers according to precious metals quotes Also Product Manager Assistant (Hotel booking - travels - agenda)

Bayer Health Care
Nov 2004 - Jan 2005Consumer Care and LogisticsSales Department and LogisticsUse of SAP for orders management Archiving Customers' database

Phidea Marvin, contractor for MSD
Mar 2005 - Apr 2011Clinical Trial AdministratorClinical Trial Administrator Documents creation and collection - translationsStudy files preparation - Study drug tracking IRB submissions Contracts negotiations and finalization, trackers updates Archiving - CTMS system updates Budget related activities: Budget negotiation: Pro Rata Budget distribution and collectionand Payment requests (EC fees / Visits payments)Invoices management - Payments advices Investigator's Meetings and Steering CommitteesDocuments reconcilation for Audits CAPA plans - Pharmacovigilance Show less

Chiltern International
Nov 2011 - Mar 2019Regulatory and Ethics Submissions - Competent Authority and Ethics Committees queries resolution until final approvalMaster Documents customization according to local requirements . Country PIS/ICF customization according to the Ethics Committees Requests Essential documents collection for site activationBudget and Contract NegotiationsFeasibilities . Documents Filing .Translations Use of Osservatorio (Italian Clinical Trials Database) and specific Ethics Committees Submissions Websites . Use of EudraCT website. CTMS activities: tracking of start up phases and documents collection .CRAs support . Study and Site files preparation .Two years as a contractor at customer's Start Up and Regulatory Department . Meetings organisation . CAPA Plan replies . Audit preparation Show less
Regulatory and Site Services Specialist
May 2011 - Mar 2019Customer's Contractor - Amgen- Regulatory Affairs Associate
Feb 2013 - Jun 2013Customer's Contractor - Alcon - CTDM Clinical Trial Documentation Manager
Nov 2011 - Oct 2012

Covance
Jan 2019 - Mar 2020Senior Start Up Specialist
Parexel
Mar 2020 - nowSenior Start Up
Licenses & Certifications

EF foreigng languanges courses
Languages
- enEnglish
- frFrench
- spSpanish
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