Mag. Silvia Benko
Angestellt, Principal Clinical Data Manager, Cytel
Hamburg, Deutschland
Werdegang
Berufserfahrung von Silvia Benko
Bis heute 3 Jahre und 8 Monate, seit Nov. 2020
Principal Clinical Data Manager
Cytel
2 Jahre und 11 Monate, Feb. 2017 - Dez. 2019
Project Data Manager/ Technical PM
Covance Clinical Development GmbH (formerly Chiltern)
2 Jahre und 3 Monate, Okt. 2014 - Dez. 2016
Senior Clinical Data Manager
ABCSG - Austrian Breast & Colorectal Cancer Study Group
1 Jahr und 7 Monate, Apr. 2013 - Okt. 2014
Clinical Data Analyst II
Edwards Lifesciences
- Study Build (eCRF design, DVS specification, UAT) in alignment with protocol - DMP, eCCGs, protocol specific conventions creation - Project Plan creation and ensure the timelines are met - Query management - Database Lock - Participation in SIVs, Monitors training/meeting - Co-operation with external vendors - Cross-functional cooperation - Study data management - SOPs preparation
10 Monate, Juni 2012 - März 2013
Clinical Data Analyst I
Edwards Lifesciences
7 Monate, Dez. 2011 - Juni 2012
Associate Data Coordinator
Premier Research
Acted as Clinical Data Manager for assigned studies in newly created team (cardiovascular, immunology, oncology therapeutic area, phases III-IV); participation in study build process (incl. designing eCRFs, UAT) and database locks; active participation in training sessions provided by Lead CDM; active participation in conference calls and providing timely, control team updates to higher management • SW used: Oracle Clinical, OC-RDC, Oracle Discoverer, JReview, Medidata RAVE, Inform
3 Monate, Sep. 2011 - Nov. 2011
Safety Data Coordinator
Premier Research
• Responsibilities included liaison with the sponsor as needed; mentored and trained associate safety data coordinators; trained and followed sponsor’s Standard Operating Procedures; issued and reviewed queries; tracked pending safety database updates; maintained and posted reconciliation spreadsheet; communicated safety status/progress/updated with the project team; performed final reconciliation before database lock • SW used: Oracle Clinical, OC-RDC, Oracle Discoverer, JReview, Argus Safety
1 Jahr und 9 Monate, Dez. 2009 - Aug. 2011
Associate Safety Data Coordinator
Premier Research
• Responsibilities included liaison with the sponsor as needed; trained and followed sponsor’s Standard Operating Procedures; issued and reviewed queries; tracked pending safety database updates; maintained and posted reconciliation spreadsheet; provided input on safety status/progress/updated to the project lead; performed final reconciliation before database lock • SW used: Oracle Clinical, OC-RDC, Oracle Discoverer, JReview, Argus Safety
• Responsibilities included BT & IT Global CF Systems Run Legacy system support and T&C management; 1st level system support for ordering systems ; T&C management; Internal customers support
Ausbildung von Silvia Benko
1 Jahr und 10 Monate, Sep. 2008 - Juni 2010
Social and Working Psychology
Comenius University
4 Jahre und 9 Monate, Sep. 2002 - Mai 2007
Biotechnology
Comenius University
Sprachen
Englisch
Fließend
Deutsch
Gut
Tschechisch
Fließend
Spanisch
Grundlagen
Slovak
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