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Maria Vlasek - Study Management, Study Coordination and Clinical Trial Monitoringin all clinical development phases on freelance basis

Clinical Research: Betreuung und Durchführung von klinischen Studien der Phasen I bis IV: Clinical Trial Monitoring, Project Management, Study Coordination, Erstellung von Clinical Trial Dokumenten, Einreichung und Meldungen bei Behörden und Ethikkommissionen, Vorbereitung und Pflege von Clinical Trial Dokumenten (TMF/ISF),Training und Übersetzungen. Clinical Research: Clinical Study Management, Coordination and Monitoring, Phase I-IV Preparation and Proof-Reading of Clinical Trial Documents, Applications t

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Maria Vlasek - Study Management, Study Coordination and Clinical Trial Monitoringin all clinical development phases on freelance basis | contract-cra.de Reviews

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Clinical Research: Betreuung und Durchführung von klinischen Studien der Phasen I bis IV: Clinical Trial Monitoring, Project Management, Study Coordination, Erstellung von Clinical Trial Dokumenten, Einreichung und Meldungen bei Behörden und Ethikkommissionen, Vorbereitung und Pflege von Clinical Trial Dokumenten (TMF/ISF),Training und Übersetzungen. Clinical Research: Clinical Study Management, Coordination and Monitoring, Phase I-IV Preparation and Proof-Reading of Clinical Trial Documents, Applications t

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Maria Vlasek - Study Management, Study Coordination and Clinical Trial Monitoringin all clinical development phases on freelance basis | contract-cra.de Reviews

https://contract-cra.de

Clinical Research: Betreuung und Durchführung von klinischen Studien der Phasen I bis IV: Clinical Trial Monitoring, Project Management, Study Coordination, Erstellung von Clinical Trial Dokumenten, Einreichung und Meldungen bei Behörden und Ethikkommissionen, Vorbereitung und Pflege von Clinical Trial Dokumenten (TMF/ISF),Training und Übersetzungen. Clinical Research: Clinical Study Management, Coordination and Monitoring, Phase I-IV Preparation and Proof-Reading of Clinical Trial Documents, Applications t

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contract-cra.de

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Maria Vlasek - Study Management, Study Coordination and Clinical Trial Monitoringin all clinical development phases on freelance basis

http://www.contract-cra.de/Experience.html

Freelancer in Clinical Research. Study Coordinator - Study Manager. Development of Clinical Trial Documents (including Amendments, Patient Information and Informed Consent Forms, Hospital-/Investigator-Contracts, Case Report Forms, Source Data Sheets). Applications to Central and Local German Competent Authorities and German Ethics Committees according to 12th Amendment to the German Drug Law and GCP-V. Organization and Coordination of Investigational Product and Study Material-Supplies. Development of P...

2

Maria Vlasek - Study Management, Study Coordination and Clinical Trial Monitoringin all clinical development phases on freelance basis

http://www.contract-cra.de/Profile.html

Freelancer in Clinical Research. Study Coordinator - Study Manager. Profile of Maria Vlasek. Since 09/2007 Clinical Site Manager (freelance work). UCB Pharma SA, Belgium. Local Coordination and Monitoring of international Phase III-Studies, indication: Morbus Crohn, Restless Legs Syndrome. Since 05/2007 Scientific Officer (freelance work). Novo Nordisk Pharma GmbH, Germany. Indication: Diabetes Mellitus (Type 1 and 2). Since 04/2007 Freelance as Study Coordinator, Study Manager. Coordination and Monitori...

3

Maria Vlasek - Study Management, Study Coordination and Clinical Trial Monitoringin all clinical development phases on freelance basis

http://www.contract-cra.de/Services.html

Freelancer in Clinical Research. Study Coordinator - Study Manager. Clinical Study Management and Coordination, Phase I-IV. Development of Clinical Trial Documents (including Amendments, Patient Information and Informed Consent Forms, Case Report Forms, Source Data Sheets). Applications to Central and Local German Competent Authorities and German Ethics Committees according to 12th Amendment of the German Drug Law and GCP-V. Proof-reading of Clinical Documentation. Perhaps I can still assist you or help ...

4

Maria Vlasek - Study Management, Study Coordination and Clinical Trial Monitoringin all clinical development phases on freelance basis

http://www.contract-cra.de/Infocenter.html

Freelancer in Clinical Research. Study Coordinator - Study Manager. Central and Local Regulatory Authorities. Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG). Medicines and Healthcare products Regulatory Agency (MHRA). National Institute for Health and Clinical Excellence (NICE). European Medicines Agency (EMEA). European Clinical Trials Database (EudraCT). US Food and Drug Administration (FDA).

5

Maria Vlasek - Study Management, Study Coordination and Clinical Trial Monitoringin all clinical development phases on freelance basis

http://www.contract-cra.de/YourBenefit.html

Freelancer in Clinical Research. Study Coordinator - Study Manager. You need Support of a flexible and qualified Freelance Expert for your Clinical Trials? Do you need . To react very fast to changes occured in the couse of a clinical trial in order not to put risk to the overall project and complete the study at the agreed time? To short term adapt human resources to ever-changing conditions and requirements? Additional capacity or resources to absorb the peaks of demand for ongoing or planned projects?

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