Lead CRA / Study Manager Freelance
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- 10115 Berlin
- Europa
- en | de | he
- 24.08.2020
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
10/2004 – 9/2017
Tätigkeitsbeschreibung
• Vendor Management
• Registration of the trial in EudraCT
• Managing site contracts and investigator payments
• Organizing of kick-off meetings and investigator meetings
• Conduct of kick-off meetings and investigator meetings
• Planning, conduct and FU of regular TCs with sponsor
• Conduct of regular safety TCs with medical monitor(s) and investigators
• Preparation and conduct of data management data/query reconciliation meetings
• Creation of weekly tracking reports and monthly reports for sponsor
• Site feasibility analysis, site selection and all types of site montoring visits (SIV to COV)
• Application for subject trial insurance
• Control of periodic safety reports to authorities
• Control of documentation for ethics committee submissions including amendments
• Review of protocols and PICs and other essential documents
• Performing site feasibility assessments with LCRA
• Control of documentation for regulatory authority submissions including amendments
• Control of CTAF, Substantial Amendment Notification Form
• Control of regular safety updates and reports to EC
• Tracking trial supplies i.e lab kits, leased equipment etc.
• Preparing for EC audits and inspections by regulatory authorities
• Working with clinical trial management systems (IMPACT)
• Working with Medidata Rave, IBM Clinical Development
• Authoring SOPs
Medizinforschung, Forschung & Entwicklung, Drug Discovery, Klinische Forschung, Klinische Arbeiten
Zertifikate
Ausbildung
University of Michigan Ann Arbor Michigan
Über mich
Indications:
• Endocrinology: DM2
• Neurological: Parkinson's Disease, Fibromyalgia
• Cardiovascular: preserved EF and reduced EF
• Oncology: colorectal, breast (advanced and metastasising), SCLC, pancreatic, hepatic
• CNS: RRMS, SPMS
• Respiratory: COPD, PAH
• ATMP: Mesenchymal Stromal Cells in Critical Limb Ischemia, Intermittent Claudication
• Neurology: Treatment resistant depression
Weitere Kenntnisse
Persönliche Daten
- Deutsch (Fließend)
- Englisch (Muttersprache)
- Hebräisch (Gut)
- Europäische Union
- Vereinigte Staaten von Amerika
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