Experience

Venn Life Sciences - part of hVIVO plc

• United Kingdom
• Research
• 1 - 100 Employee

• Clinical PK-PD Study Auditor

  • Jul 2021 - Present

  Performing audit of Study Plan, Study File and Final Report of PK/PD studies.Tracking the audits on the dedicated database and keep this database up to dateEnsuring the follow up of audit reports

• Archivist

  • Sep 2019 - Present

  Ensuring the selection and management of a vendor for long-term archiving;Ensuring the archiving, retrieval and destruction/return to sponsor of documents at external vendor archiving facility;Maintaining an up-to-date archiving list of all documents archived, retrieved and destroyed.

• Quality Assurance Administrator

  • Jan 2016 - Present

  (40% from 2016 to 2018, 100% from 2018 until today)Creation and administrative management of all the trackers of the QA department concerning Procedural Documents, CAPAs, Audits, Vendor Qualifications, Setting up and administrative management of Quality SharePoint pages,Quality Check of Procedural Documents,Tracking and reporting of key performance indicators/metrics,Administrative support to auditors.

• Clinical Trial Assistant

  • Jan 2016 - Jan 2018

  Study follow-up, maintenance: update of administrative documents, tracking sheets, reconciliation between regulatory documents and various systems.Suivi logistique des essais (gestion de matériel, coordination de transport d'échantillons);Clôture des essais40% QA administrator / Procedure Document controllerChargée de suivi du système de mangement des documents (suivi des revue et validation des nouveaux documents - SOP, WI, GP, templates et forms)Diffusion des informations au service de formation Show less

• Clinical Trial Assistant

  • Jan 2014 - Jan 2016

  Outsourced at NovartisAverage: 15 protocols (Neurology et Transplantation), around 100 sitesAdministrative and logistics management of phases 3 et 4 studies, update of administrative documents, tracking sheets,Support for Close Out Visit (co-visit) and administrative clean-up for study archiving,Creation and Implementation of new tracking tools.



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Trial Assistant

  • Jan 2011 - Jan 2014

  Outsourced at Amgen. Average: 7 protocols (oncology et general medicine) 70 sites Participation to feasibilities, administrative submissions to Ethics Committee, and other French regulatory authorities. Phase 1, 2, 3, 3b and 4 site initiations: creation and compiling of regulatory documents, creation of TMF (eTMF and binders); study follow-up, maintenance and archiving: update of administrative documents, IT systems and tracking sheets, reconciliation between regulatory documents and various systems; Contact CTA for: document quality, study close-out and archiving, investigator brochures, member of the working group between Clinical Trial Assistants and Clinical Research Associates. Show less



Projects Abroad PRO

• United Kingdom
• International Trade and Development
• 1 - 100 Employee

• Assistant manager

  • Apr 2010 - Sep 2010

  MEXICO – Sea turtle preservation center Planning and participation to volunteering activities at the camp and residence organization; Daily supervision of foreign volunteers; Bi-weekly administrative reports sent to Projects Abroad head offices in England. MEXICO – Sea turtle preservation center Planning and participation to volunteering activities at the camp and residence organization; Daily supervision of foreign volunteers; Bi-weekly administrative reports sent to Projects Abroad head offices in England.



Citeo

• France
• Environmental Services
• 300 - 400 Employee

• Assistant at the IDF Regional Management

  • Jun 2007 - Feb 2009

  (Organization for the packaging sorting and recycling) Reception desk: physical reception, phone calls filtering, agenda and various stock management; Organization of events and travels within budget control: • visits to optimized syndicate in waste processing, training sessions, • participation to meetings and various events (exhibitions, shows). (Organization for the packaging sorting and recycling) Reception desk: physical reception, phone calls filtering, agenda and various stock management; Organization of events and travels within budget control: • visits to optimized syndicate in waste processing, training sessions, • participation to meetings and various events (exhibitions, shows).



Université d'Évry

• France
• Higher Education
• 200 - 300 Employee

• Training Manager

  • Feb 2003 - Jun 2007

  End-of-term examinations organization: grade data entry and jury organization; Interface contact between students and teachers; Student administrative management, Student reception and advising for future education options and regulations assessment tests. End-of-term examinations organization: grade data entry and jury organization; Interface contact between students and teachers; Student administrative management, Student reception and advising for future education options and regulations assessment tests.



Norbert Dentressangle

• Brétigny sur Orge

• Administrative Employee

  • Jul 2002 - Jan 2003

  At the reception desk for a month: physical and phone reception, invoicing; At the preparation and shipment department from August 2002: planning of vehicles at the pick-up platform, management of the loading team, truck chartering, order dispatching. At the reception desk for a month: physical and phone reception, invoicing; At the preparation and shipment department from August 2002: planning of vehicles at the pick-up platform, management of the loading team, truck chartering, order dispatching.