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Letztes Update: 16.11.2020

Sr. CRA,PM, MSL, DACH, Germany, Ukraine

Abschluss: nicht angegeben
Stunden-/Tagessatz: anzeigen
Sprachkenntnisse: deutsch (verhandlungssicher) | englisch (gut) | polnisch (gut) | ukrainisch (Muttersprache)

Schlagwörter

Skills

Seit 2007 arbeite ich in der klinischen Forschung.
2012 habe ich mich selbstständig gemacht und arbeite als Projekt-CRA & Medical Projekt Manager in unterschiedlichen Indikationen.

Projekthistorie

since
Feb.  2014:                              Project CTM/Lead CRA and Senior Clinical Research Associate
                                               Responsibilities:
 As CTM- coordination and management international CRAs team, Study budget tracking, review of CRO study documents, quality of all study deliverables, project management global Studies Phases I-III, MV Report Reviews, CRAs Mentor, Track patient recruitment and progress to study timelines.
                                              
As Sr. CRA- monitors investigational sites to ensure subject safety and provide high quality data review and reporting in compliance with the project SOPs, GCP/ICH guidelines and other applicable regulations. Builds, manages and supports strong site relationships while serving as liaison between the Sponsor and assigned sites, Phases I-IV.
 Karyopharm, Clinipace, IncResearch, CROMSOURCE
 
2012-2014:                               Medical Project Manager MSL Oncology

Responsibilities: Scientific, clinical and educational support to study sites and CROs (Full life cycle management from start-up and initiation, collection of study data & data quality, AEs/SAEs, eCRF training), recruitment-supporting measures, workshops, investigators & site staff training, advisor boards, Phases IIIb-IV. Novartis AG.
           
2007 - 2012                                          Trial Manager, leading Trial Project Team & responsible for the forecasting, planning, coordination, and execution of key supply chain activities in support of the global phase I – IV clinical program, clinical study protocols review, preparation regulatory documents for IMPD/IND filings, support generation of IVRS specifications and User Acceptance Tests, update and maintains cost estimate files. Boehringer Ingelheim Pharma GmbH & Co. KG
2007-2007                                 Project-CRA, Monitoring (periodical Monitoring Visits,                                                   Close-Out Visit) Oncology, AAI Pharma.
 
2006-2007                                 Regulatory Affairs Manager, Responsible for coordination & preparation of regulatory submissions, Update licensing and collect information on registration instructions and regulations, Dosiers update, Variations. AWD.pharma GmbH & Co. KG
 

Reisebereitschaft

Verfügbar in den Ländern Deutschland
Profilbild von Anonymes Profil, Sr. CRA, PM,  MSL, DACH, Germany, Ukraine Sr. CRA,PM, MSL, DACH, Germany, Ukraine
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