MacArena Gargiulo
Manager Development Clinical Operations and Quality at Endosane Pharmaceuticals
Based in Mannheim, Germany
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Seniority
Manager
Department
Other
Location
Mannheim
Industry
Pharmaceutical Manufacturing
Company size
10
Contact information
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m•••••••@endosane.com
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Background
About MacArena Gargiulo
Working in clinical research for 16 years, starting as a Clinical Research Associate (CRA), progressing to Clinical Team Lead (CTL), Site Visit Report Quality Reviewer (SVRQRs) and Functional Manager. From 2004 to 2009 role of CRA and CTL, involved in multi center studies Phase II, and IV. Responsibilities have spanned the start-up process until close-out. Role of dedicated Site Visit Report Quality Reviewer (SVRQR) from 2010 to 2011, working across eight protocols, responsible for the review of reports for all aspects of a clinical trial across a broad range of therapeutic areas, ensuring compliance to the protocol, ICH/GCP and company requirements. From 2011 to 2013, Manager responsibilities within the SVRQRs Team. From 2014 to 2016, Manager of Clinical Operations in the Late Phase Team at PRA, leading the Site Management Team and overseeing the clinical and/or monitoring aspects of late phase studies. Since March 2016, Clinical Operations Manager at Linical.
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