Clinical Operation Expert
- Verfügbarkeit einsehen
- 0 Referenzen
- auf Anfrage
- 60437 Frankfurt am Main
- Weltweit
- it | en | de
- 31.03.2025
Kurzvorstellung
18+ years experience in Trial/Program management as well as support in all aspects of clinical operation and development. I can support you in running your clinical project in time and within budget.
Qualifikationen
Ausbildung
Dr.
Dr in Biochemie
J.W.Goehte
2004
Frankfurt am Main
Frankfurt am Main
Weitere Kenntnisse
Inspection Readiness:
- Audit preparation & conduct
- SOP writing
- Implementation of inspection-relevant processes
- CRO qualification and selection, risk assestment etc.)
- TMF check
Regulatory and Clinical Writing
Authoring/Reviewing of CTP, ICF, CSR, submission packages, monitoring plan & other trial related documents
Clinical Development
- Transition from pre-clinical to clinical phase
- Building and leading cross-functional teams
- Support in finalization of the Clinical Development Plan
- Audit preparation & conduct
- SOP writing
- Implementation of inspection-relevant processes
- CRO qualification and selection, risk assestment etc.)
- TMF check
Regulatory and Clinical Writing
Authoring/Reviewing of CTP, ICF, CSR, submission packages, monitoring plan & other trial related documents
Clinical Development
- Transition from pre-clinical to clinical phase
- Building and leading cross-functional teams
- Support in finalization of the Clinical Development Plan
Persönliche Daten
Sprache
- Englisch (Fließend)
- Deutsch (Fließend)
- Italienisch (Muttersprache)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
- Europäische Union
Home-Office
bevorzugt
Profilaufrufe
42
Alter
51
Berufserfahrung
18 Jahre und 9 Monate
(seit 07/2006)
Projektleitung
18 Jahre
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