Koutra Vaia
Clinical Research Associate Manager at Novartis Baltics- Claim this Profile
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Bio
Experience
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Novartis Baltics
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Clinical Research Associate Manager
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Apr 2022 - Present
Responsible for the hiring, training, development, and assignment of CRAs for 3 countries: Latvia, Lithuania, Estonia to ensure qualified Monitoring resource assignment to the Global Drug Development (GDD) portfolio. Responsible for CRA quality and compliance of clinical monitoring activities related to investigator site qualification, initiation, and trial conduct; for CRA performance in accordance with Good Clinical Practice and local regulations. Coordinate CRA meetings for 3 countries (Latvia, Lithuania, Estonia) Collaborate with Clinical Trial Assistants, Clinical Research Medical Advisor, Global Trainers and Process Control Managers; develop activities that enhance team's commitment Show less
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Novartis (Hellas) S.A.C.I.
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Athens
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Clinical Research Associate Manager
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Jan 2018 - Present
Responsible for the hiring, training, development and assignment of Clinical Research Associates to ensure Monitoring to the Global Drug Development portfolio trials. Responsible for the hiring, training, development and assignment of Clinical Research Associates to ensure Monitoring to the Global Drug Development portfolio trials.
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Novartis
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Jan 2014 - Jan 2023
As a Clinical Study Manager I am accountable for planning, executing and reporting on a number of phase I-III, global phase IV clinical studies for a country or cluster, from planning through study close-out. This position is key to good communication and professional relationships with clinical investigators and international colleagues in HQs and CPOs.
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Oct 2007 - Dec 2013
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Education
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University of East London
Bachelor's degree, Biomedical Sciences, General -
Aristoteleion Panepistimion Thessalonikis
Bachelor's Degree -
University of East London
Master of Business Administration (M.B.A.), MBA in International Business