Heike Müller-Spitzer
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Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Heike Müller-Spitzer
Oversight about monitoring activities; Support of IND/IRB submissions incl. review/approval of submission docs; Preparation and/or review of essential docs/study manuals; Set-up/management of eDiary with eDiary provider; Set-up of EDC with EDC provider; Set-up/day-to-day management of Central Lab; Co-Monitoring of sites; Organization of CRA trainings/internal/external meetings; Liaison between sponsor and third party vendors; Transition of a clinical trial from one CRO to another CRO
Contribution to the overall preparation of an Europe-based post authorisation study, Contribution to the overall execution and management of a national non-interventional study, Monitoring of sites
- 1 year and 5 months, Oct 2011 - Feb 2013
Specialist II Clinical Trials
ImClone Systems International (wholly-owned subsidiary of Eli Lilly and Company)
Contribution to the overall preparation, execution and management of global clinical trials (phase II-III), Study site management, Management of external vendors, Co-monitoring at sites
- 9 months, Jan 2011 - Sep 2011
Specialist Clinical Trials
ImClone Systems International (wholly-owned subsidiary of Eli Lilly and Company)
Contribution to the overall preparation, execution and management of global clinical trials (phase II-III), Study site management, Management of external vendors, Co-monitoring at sites
- 1 year and 3 months, Oct 2009 - Dec 2010
Clinical Trial Assistant
Imclone Systems International (wholly-owned subsidiary of Eli Lilly and Company)
Contribution to the overall preparation, execution and management of global clinical trials (phase II-III), Study site management, Management of external vendors, Co-monitoring at sites
- 10 months, Dec 2008 - Sep 2009
Senior IMP Manager
IFE Europe GmbH
Management of manufacuture and handling of IMP and other drug related supplies
- 1 year and 7 months, Jun 2007 - Dec 2008
Assistant to Drug Management
IFE Europe GmbH
Management of manufacture and handling of IMP and other drug related supplies
- 4 years and 11 months, Jul 2002 - May 2007
CRA Assistant
IFE Europe GmbH
Trial Supply Management, Project Assistance, In-house Monitoring, Trial Master File maintenance, Study site management, Database maintenance
Sprachen
German
C2 (Verhandlungssicher / Muttersprachlich)
English
C1 (Fließend)
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