
Clinical Trial Educator at Schering-Plough SAS from RPS Research Pharmaceutical Services, Inc.
Paris Area, France

Clinical Trial Educator at Schering-Plough SAS from RPS Research Pharmaceutical Services, Inc.
Paris Area, France
Previously as Project Manager in an international CRO :
Manage activities of national and international Clinical Trials Projects (monitoring, medical biometry and writing, reglementary submissions, administratives tasks)
Secure quality, milestones and deadlines
Previously as Site Operations Coordinator and Local Trial Manager/Senior Monitor in a pharmaceutical compagny :
Both activities below allocated to Key Projects/Trials
Previously as Patient Recruitment Manager :
Regional (15 countries / 45 sites in EU) responsibility of the recruitment plan
Responsible for the consistency of trial performance, for coordinating knowledge sharing between relevant stakeholders, for continuous challenge of investigational site activity and performance
Previously as Local Trial Manager / Team Leader in a pharmaceutical compagny :
Management of in or outsourced Clinical Trials (Phase I to Phase III), Management of CRO or CRAs
Budget, Protocol review, design of Case Report Forms and Monitoring Guide, Feasibility in compliance on Bussiness Alignement, Recruitment of general or hospital investigators, Experts meeting and lobbying in collaboration with marketing/sales departments, Administrative preparation and Regulatory submission, Initiation, Monitoring or Co-monitoring, Medical checking, Data entry, preparation of Audits, centre Closure, Archieving
Collaboration in SOPs revision and Experience sharing working groups
Training of CRAs, Sharing fields expertise with HQ management
Previously as Monitor from a national CRO :
monitoring of Clinical Trials from homebasement in Paris (Phase II to phase IV)
Management of experimental and preclinical trials in Physiology, Pharmacology and Behavior – CNS, Metabolism and Oncology (Cachexia) :
Bibliography surveillance, analysis and summary of the litterature, experts meeting and lobbying, design and conduct of “in vitro" and "in vivo" studies,
reporting and publication, internal meetings and congresses
A multidisciplinary Med. Biol. Scientist specialised in human pathophysiology:
- Clinical research (phase I, II, III and IV trials - GCP) after -Basic research and applied preclinical research (GLP)
(Pharmaceuticals industry)
June 2009 — Present (2 months)
To raise awareness of the TRA-CER trial to ensure that it stays top of mind at targeted sites when considering patient enrollment
Provide all appropriate study site personnel with information/training in regards to the disease state/study/drug/published data
Act as a liaison between TRA-CER sites, Country Operation and Schering Plough Research Institute
(Privately Held; Pharmaceuticals industry)
March 2009 — June 2009 (4 months)
Manage Clinical Projects activities (monitoring, medical biometry, medical writing, reglementary submissions and other administrative tasks) to reach stakeholders satisfaction
Secure quality, deadlines and milestones projects key achievements
(Privately Held; Pharmaceuticals industry)
September 2008 — February 2009 (6 months)
Apply recruitment management to different projects at same time than monitoring and local trial management in France
(Privately Held; NVO; Pharmaceuticals industry)
February 2007 — December 2008 (1 year 11 months)
(Public Company; NVO; Pharmaceuticals industry)
May 2001 — December 2006 (5 years 8 months)
CESAM Management of Clinical Trials , Clinical Trials Management - Methodology and Statistics , 1996 — 1997
Med. Biol. Sciences , Pathophysiology, Biochemistry and Pharmacology , 1985 — 1992
DUT Applied Biochemistry and Biology , Biology, Biochemistry, Physiology, Pharmacology , 1980 — 1982
Baccalauréat Série D , High School , 1973 — 1980
Family social and cultural activities Literature (historitical romans) and running (cross-country)
Active member of a local working group in the town ("town planning and community of life")
Operating Fireman in the Paris Fire Brigade (1984-1985)
Organiser of summer camps for Children and Adolescents (1978-1984)