2006-10 ? 2008-09
Role: Project Manager
Project Management including budget responsibility and line management for national and international studies, phase I and III, attending and presenting at investigator and bid defence meetings.
2008-10 - 2009-06
Role: Medical Monitor
Responsible for Medical Monitoring and Drug Safety of international studies phase II ? III
CRA
Project Management of national and international studies phase III: Effectively manage of all aspects of assigned clinical trials according to the specificities of the sponsor?s contract; Control project team activities to ensure ICH-GCP guidelines and SOPs are strictly observed, including study preparations, site initiations, periodic monitoring, status and safety reporting; Regularly meet and liaise with sponsor to ensure study conduct and completion are progressing according to sponsor needs and established study timelines; Coordinate all ancillary aspects of the study, including vendor management, data management, pharmacovigilance, statistician, and medical writer
Medical Writer
Writing of 6 integrated study reports, 1 CRF and 1 Protocol
CRA
Monitoring of clinical studies phase II and IV, initiation and recruiting phase, maintenance of regulatory files, SAE reporting, attendance of investigator meetings
Dissertation
1992 - 1998
University of Cologne
title of Dissertation: on Request
Studies
1985 -1992
University of Cologne
Human medicine (MD)
Graduation: License to practice medicine
1974 - 1983
Secondary school in Leverkusen
Graduation: University-entrance diploma
1970 - 1974
Primary school in Leverkusen
Civilian Service
1984-04 ? 1985-02
Mobile social service, ?Arbeiterwohlfahrt?, Cologne
1983-11 ? 1984-03
Home for the aged in Leverkusen
Resident
1996-01 ? 1996-06
Rheinische Landes ? und Hochschulklinik Düsseldorf (Psychiatry)
1994-10 ? 1995-09
Private practice Dr. Storch, Düren (Nuclear medicine
2006-10 ? 2008-09
Role: Project Manager
Project Management including budget responsibility and line management for national and international studies, phase I and III, attending and presenting at investigator and bid defence meetings.
2008-10 - 2009-06
Role: Medical Monitor
Responsible for Medical Monitoring and Drug Safety of international studies phase II ? III
CRA
Project Management of national and international studies phase III: Effectively manage of all aspects of assigned clinical trials according to the specificities of the sponsor?s contract; Control project team activities to ensure ICH-GCP guidelines and SOPs are strictly observed, including study preparations, site initiations, periodic monitoring, status and safety reporting; Regularly meet and liaise with sponsor to ensure study conduct and completion are progressing according to sponsor needs and established study timelines; Coordinate all ancillary aspects of the study, including vendor management, data management, pharmacovigilance, statistician, and medical writer
Medical Writer
Writing of 6 integrated study reports, 1 CRF and 1 Protocol
CRA
Monitoring of clinical studies phase II and IV, initiation and recruiting phase, maintenance of regulatory files, SAE reporting, attendance of investigator meetings
Dissertation
1992 - 1998
University of Cologne
title of Dissertation: on Request
Studies
1985 -1992
University of Cologne
Human medicine (MD)
Graduation: License to practice medicine
1974 - 1983
Secondary school in Leverkusen
Graduation: University-entrance diploma
1970 - 1974
Primary school in Leverkusen
Civilian Service
1984-04 ? 1985-02
Mobile social service, ?Arbeiterwohlfahrt?, Cologne
1983-11 ? 1984-03
Home for the aged in Leverkusen
Resident
1996-01 ? 1996-06
Rheinische Landes ? und Hochschulklinik Düsseldorf (Psychiatry)
1994-10 ? 1995-09
Private practice Dr. Storch, Düren (Nuclear medicine