Sandra Scheidl

ist offen für Projekte. 🔎

Angestellt, Director Clinical Program, Gouya Insights
Wien, Austria

Fähigkeiten und Kenntnisse

Several years of experience in Clinical Data Manag
Electronic Studies (Start Up Phase; Phase I-IV Stu
CRF Design (paper and electronic based Studies)
Data Cleaning/Query Management
Protocol Reviews
Development of Standards (e.g. CRFs; DMPs)
UAT Testing incl. development of Testplans
Onsite Testing
User Trainings
Development of Edit Checks
Process development for EDC implementation (Study
Elaboration of Standard Operating Procedures (SOPs
Work with international Teams
Medidata RAVE experiences (Study Build; Integratio
Software Validation
ERP-Projekte
JD Edwards Enterprise One
Supply Chain
Datenmanagement

Werdegang

Berufserfahrung von Sandra Scheidl

  • Current 3 years and 5 months, since Jan 2023

    Director Clinical Program

    Gouya Insights

  • 6 months, Jun 2022 - Nov 2022

    Head of Clinical R&D

    P+F Products + Features GmbH

  • 2 years and 1 month, May 2020 - May 2022

    Clinical R&D/Quality Manager

    P+F Cardiovascular GmbH

  • 2 years and 6 months, Nov 2017 - Apr 2020

    Clinical Data Management and IT

    Koordinationszentrum für Klinische Studien (KKS), Medizinische Universität Wien

  • 1 year and 5 months, Jun 2016 - Oct 2017

    Business Analyst B2B Solutions

    Shire (Baxalta AG, Now part of Shire)

  • 1 year and 5 months, Jan 2015 - May 2016

    Business Systems Analyst

    Baxalta AG

  • 2 years and 3 months, Oct 2012 - Dec 2014

    Clinical Systems Analyst

    Baxter Innovations GmbH

    Perform electronic data capture systems (EDC) database setup for clinical studies including specification, programming, testing, maintenance and customer training according to Standard Operation Procedures and project timelines. Acquire fundamental knowledge of customer needs/preferences, address issues promptly, and propose solution to recurring problems. Interact with Contract Research Organizations (CROs), laboratories and technology vendors to support database setup.

  • 1 year and 8 months, Mar 2011 - Oct 2012

    Clinical Data Analyst

    Baxter Innovations GmbH

    Support of data management project activities according to SOPs Preparation of DM Plan, CRF design, CRF flow definition, database setup and validation, development of test plans, Query Management , data reporting, creation of snapshots and execution of database locks. Work with External Service Providers if studies/study parts are outsourced. Participation in and status reporting into project team meetings, etc...

  • 3 years and 8 months, Jul 2007 - Feb 2011

    Assoc. Clinical Data Analyst

    Baxter Innovations GmbH

  • 4 years and 7 months, Dec 2002 - Jun 2007

    Clinical Data Coordinator

    Baxter AG

  • 2 years and 10 months, 2000 - Oct 2002

    Assistentin der Geschäftsführung

    Buw Wien

Ausbildung von Sandra Scheidl

  • 1 year and 8 months, Nov 2008 - Jun 2010

    IT in Healthcare and Life Science

    Donau Uni Krems

Sprachen

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    C1 (Fließend)

  • French

    A1-A2 (Grundkenntnisse)

  • Serbokroatisch

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