Christina Rude (née Fehér)
Angestellt, Manager, Clinical Operations (Oncology), Syneos Health Clinical Solutions (Previously INC Research/inVentiv Health)
Mannheim, Deutschland
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