Beschreibung

I am looking for new opportunities to enable companies to better manage their eTMF, migrate or implement their new Veeva eTMF. I can help on many business aspects of your eTMF ie access management, template and archiving management. My strong experience in clinical operations allow me to better understand the business needs. I can train and support your team using Veeva eTMF.

Sprachen

Französisch
Muttersprachlich oder zweisprachig
Englisch
Verhandlungssicher
Spanisch
Konversationssicher

Arbeitsortpräferenzen

Nur remote

Führt Projekte hauptsächlich remote aus

GSK Consumer Healthcare
Business Administrator VEEVA -Principal Clinical Studies Manager
PHARMAZEUTISCHE INDUSTRIE
August 2015 - April 2022 (6 Jahre und 8 Monate)
1260 Nyon, Switzerland
1.Business administrator Veeva eTMF :
•Act as Business Support Analyst for implementation of Veeva eTMF for GSK enterprise
•Configure updates and system releases and upgraded with Veeva and Tech Team
•Business led test cycles and led UAT scripts development, update, and execution
•DIA Reference Model expert
•Maintenance of access management, template management, archiving oversight and report management
•Develop and deliver system training strategy and materials
•Ticket management and support business team
•Key interface between clinical development, Tech Team and eTMF system matters
•Ongoing Data Quality checks and Management Monitoring. Provide inputs on system compliance (GCP requirements) and support inspection readiness
2.Clinical operations manager for international clinical trials (phase 1 to 4) with several CROs
3.Business administrator eTMF and Clinical documentation using a Documentum based eDMS
Migration Business Administration Privileged Access Management Gestion des tickets Formation
Novartis Consumer Health
Business Administrator Documentum -Principal Clinical Studies Manager.
PHARMAZEUTISCHE INDUSTRIE
März 2005 - August 2015 (10 Jahre und 5 Monate)
1260 Nyon, Switzerland
1.Business administrator eTMF and Clinical Documentation using a Documentum based eDMS :
•Organize migration from previous document management systems
•Business lead in system test and led UAT scripts update, and execution
•Maintenance of template management, and report management
•Develop and deliver system training materials
•Interface between clinical development and Tech Team
•Configure and customize the electronic document management repository for the clinical department enabling integration of documentation (eTMF) throughout Novartis Consumer Health
2.Principal Clinical Studies Manager:
•Clinical operations management for international clinical trials (phase 1 to 4) using several CROs
•Posting studies on public institutional web sites (Germany, USA, EMEA, Sponsor website)
Amitis, Staticon and Sanofi
4Clinical Operations Manager
PHARMAZEUTISCHE INDUSTRIE
Januar 2000 - September 2004 (4 Jahre und 8 Monate)
Paris, France
Management of clinical studies for pharmaceutical companies: phase IV, (Ophthalmology, Dentistry) and Phase III, (Pain) and CNS