Mes compétences :
Bilingual
Chef de projet
Clinical trials
Etude clinique
International
Projet international
R&D
Gestion de projet
Industrie pharmaceutique
Entreprises
HRA Pharma
- Clinical Trial Coordinator
2010 - maintenantCLINICAL TRIAL COORDINATOR
• Participation in early discussions based on company needs/strategy to design study outline.
• Preparation of all clinical study documentation in English including collaboration with experts (medical, methodological experts, etc)
• Study set-up activities including:
- Budget planning & accountable for budget management throughout study
- Preparation of study timelines & accountable for meeting deadlines throughout study
- Outsourcing management: from identification of outsourcing needs to contracting process.
- Management of investigational sites.
• Study conduct activities including:
- Conduct of site initiation visits
- Management of subcontractors
- Monitoring study progress & Reporting to management
• Analysis & close-out activities:
- from Facilitator of blind review meetings before database lock to coordination of medical writing activities.
Collaborations with:
World Health Organization - ph III in pericoital contraception
FHI360 (Family Health International) - ph III in pericoital contraception
PROJECT TEAM LEADER (PTL)
- Leader of a multi-disciplinary team in charge of for activities/studies necessary to file a new drug application
- Responsible for tracking good management of overall budget (budget approx. 8M€) and timelines
- Interface between project team and upper management.
Skills acquired as PTL:
- Understanding of patents
- Overview of market access
- Preparation of clinical development plan (different scenarios & associated budget/timelines)
- Input into regulatory strategy & consultation of regulatory authorities (MHRA - UK, FDA - US)
- Input into Business plan
- Presentations to upper management
Clinact (CRO), France
- Coordinateur d'études cliniques
2007 - 2010Dec 09 to Jun 10: CLINICAL TRIAL COORDINATOR contracted out to HRA PHARMA - contraception/women's health.
April 09 to Dec 09: TRIAL MANAGER contracted out to SANOFI-AVENTIS responsible for the set-up of a large international phase IV clinical trial in the field of atrial fibrillation (Multaq - dronedarone)
July 08 to March 09: CLINICAL TRIAL COORDINATOR contracted out to HRA PHARMA coordinating a phase III study in the field of emergency contraception. Collaboration with PPFA – Planned Parenthood of America (US)
Budget approx. 2M$
July 07 to June 08: HEAD OF CLINICAL STUDIES contracted out to SERVIER to work on a multinational phase III study with Diamicron (gliclazide) in type II diabetes for 6 months, later responsible for the set-up of a phase I study in diabetes conducted in a patient population.
Roche Products Ltd, UK
- Manager d'études de pharmacologie clinique
2003 - 2007Manager d'études de pharmacologie clinique:
- responsable de la coordination des études de phase I du développement du synopsis jusqu'à la finalisation du rapport d'étude clinique en passant par la rédaction du protocole, la faisabilité et la sélection des sites investigateurs, management du budget de l'étude, fourniture des produits, des kits de PK, participation au design du CRF, visites de mise en place, de monitoring et de cloture, etc.
Roche Products Ltd, UK
- Spécialiste en pharmacovigilance bilingue
1999 - 2003- case management des cas d'évènements indésirables spontanés et des cas graves des études cliniques dans la base de données de pharmacovigilance de l'entreprise.
- Travail en collaboration avec les médecins PV pour gérer l'évaluation des cas.
- Traduction des cas émanant de la filiale France.
Formations
Kingston University (Kingston Upon Thames)
Kingston Upon Thames1995 - 1998BSc (Honours) Medicinal Chemistry
