Maya U.
Senior Clinical Research Associate @ICON plc
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WORK HISTORY
Senior Clinical Research Associate @ICON plc
Berlin, DE
EDUCATION
Universitat de València
Erasmusaustausch
Universität Ulm
Tropenökologie Kurse
Freie Universität Berlin
Diplom
Universidade Federal Rural de Pernambuco
Reproduktive Biologie
PAREXEL Academy
Clinical Monitor and Logistic Manager
ABOUT MAYA U.
15 years of experience in clinical trials as CRA and CPM. Parexel Academy: Trainee and Student (professional training as a Clinical Monitor and Logistic Manager) expert knowledge: Clinical Project Manager, oversight of Clinical Research Activities, Clinical Monitoring Phase I - IV Trial Management of national clinical studies in accordance with GCP, applicable local laws, international guidelines and SOPs, Vendor management, personal responsibility e.g. oversight of CRA activities at the different sites in different countries, guiding and mentoring the Clinical Coordinators, preparation and performing of telephone conferences with vendors and sponsor, oversight of Trial Master File, preparation of study relevant documents, e.g. ICF, protocol, Monitoring Plan, Site documents, budget responsibility Herbal medicinal products, food supplements Indications: Oncology: Metastatic Castrate Resistant Prostate Cancer (mCRPC)(phase II); Renal Cell Carcinoma (phase Haematology; Haemophilia A (phase Polycythemia vera (phase Rheumatoid Arthritis (phase IV); Chronic renal failure after cardiac transplantation (phase Heart-Lung Transplantation (phase Cardiology Artrial fibrillation (phase further education: Coaching training
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