Christina Rude (née Fehér)

Angestellt, Manager, Clinical Operations (Oncology), Syneos Health Clinical Solutions (Previously INC Research/inVentiv Health)

Mannheim, Deutschland

Fähigkeiten und Kenntnisse

Onkologie
Klinische Studien
Klinisches Monitoring
GMP
Klinische Forschung
CTMS
Monitoring

Werdegang

Berufserfahrung von Christina Rude (née Fehér)

  • Bis heute 2 Jahre und 6 Monate, seit Dez. 2021

    Manager, Clinical Operations (Oncology)

    Syneos Health Clinical Solutions (Previously INC Research/inVentiv Health)

    - Line management of ClinOps staff (incl. admin oversight, professional development, appraisals, counselling, assignment of project work [ensuring projects are suitably resourced etc] - Participation in interview process & new hire on boarding - Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) & compliance with federal and local guidelines & ICH GCPs - Conduct of sign off & assessment visits - Organizes & chairs clinical staff meetings

  • 3 Monate, Sep. 2021 - Nov. 2021

    Clinical Trial Manager II (COL retitled CTM II; Oncology)

    Syneos Health Clinical Solutions (Previously INC Research/inVentiv Health)

  • 2 Jahre und 9 Monate, Dez. 2018 - Aug. 2021

    Clinical Operations Lead (COL; Oncology)

    Syneos Health Clinical Solutions (Previously INC Research/inVentiv Health)

  • 11 Monate, Jan. 2018 - Nov. 2018

    Lead/Senior Clinical Research Associate (Oncology)

    Syneos Health Clinical Solutions (Previously INC Research/inVentiv Health)

    Lead CRA: - Responsible team member clinical/site managing study deliverables as functional Lead CRA - Evaluate and reports direct report workload forecast and trends - Attends and presents monitoring/site management status during sponsor meetings - Routinely review CTMS, CRF, TMF, Drug Management - Review content and quality of monitoring documentation - Line Management responsibility for staff member (since Feb2017)

  • 2 Jahre und 3 Monate, Okt. 2015 - Dez. 2017

    Lead/Senior Clinical Research Associate (Oncology)

    INC Research

    Lead CRA: - Responsible team member clinical/site managing study deliverables as functional Lead CRA - Evaluate and reports direct report workload forecast and trends - Attends and presents monitoring/site management status during sponsor meetings - Routinely review CTMS, CRF, TMF, Drug Management - Review content and quality of monitoring documentation - Line Management responsibility for staff member (since Feb2017)

  • 1 Jahr, Okt. 2014 - Sep. 2015

    Senior Clinical Research Associate (Oncology)

    INC Research

    Senior CRA: - Monitoring (PSSV, SIV, RMV, COV) - Reporting and tracking (study deliverables) - Data Management (analytical thinking) - IP Management (inventory, reconciliation) - Record keeping (ISF and TMF) - Training or mentorship on junior CRAs

  • 1 Jahr und 7 Monate, März 2013 - Sep. 2014

    Senior Clinical Research Associate

    Covance

  • 4 Jahre und 7 Monate, Aug. 2008 - Feb. 2013

    Clinical Research Associate (Oncology)

    INC Research

  • 1 Jahr und 5 Monate, Apr. 2007 - Aug. 2008

    Clinical Research Associate

    i3 Research

  • 4 Jahre und 7 Monate, Okt. 2002 - Apr. 2007

    MTLA

    DKFZ

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

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