Dr. Ariuna Liga
Angestellt, Country Study Manager, Roche Pharma AG, Grenzach-Wyhlen, Deutschland
Staufen im Breisgau, Deutschland
Werdegang
Berufserfahrung von Ariuna Liga
Bis heute 8 Jahre und 8 Monate, seit Okt. 2015
Country Study Manager
Roche Pharma AG, Grenzach-Wyhlen, Deutschland
1 Jahr und 3 Monate, Jan. 2014 - März 2015
Local Study Manager
GlaxoSmithKline, Moskau, Russland
• Planning, conduction and management of all clinical activities on a country level on time, within budget, and in compliance with local regulations, SOPs and ICH GCP guidelines • Study feasibility and selection of suitable hospitals/clinics/investigators, CROs and CRAs • Local study budget composition • Submission and obtaining of study ethics and regulatory approvals including export/import licenses • Organization of Investigator Meetings, study-specific trainings for investigators and CRAs
1 Jahr und 1 Monat, Jan. 2013 - Jan. 2014
CRA Team leader
GlaxoSmithKline, Moskau, Russland
• Line management, control of CRAs workload, coaching, support and training of the in-house CRAs' subgroup (3 CRAs), co-monitoring visits • Support of Head of Field Monitoring in conduction of quarter CRAs meetings, recruitment of new CRAs • All types of monitoring (Pre-study, Initiation, Routine Monitoring, Close-out Visits, Adaptive Site Monitoring) of investigator sites for Phase II-III Studies (Respiratory, Immunology, Oncology)
2 Jahre und 1 Monat, Dez. 2010 - Dez. 2012
Clinical Research Site Manager
GlaxoSmithKline, Moskau, Russland
• All types of monitoring (Pre-study, Initiation, Routine Monitoring,Close-out Visits, Adaptive Site Monitoring) for Phase I-III Studies (Respiratory, Immunology) • Support of Local Study Manager in conduction of Investigator Meetings, development of guidelines for investigators for maintaining of patients' source documents • Conduction of clinical trials within the country, management of distribution, collection and destruction of study materials and clinical trial supply material
1 Jahr und 10 Monate, März 2009 - Dez. 2010
Clinical Research Associate II, I
CRO Synergy Research Group (SynRG), Moskau, Russland
• Monitoring (Pre-study, Initiation, Routine Monitoring Visits) of investigator sites for a Phase III study (Cardiology) • Support of Project Manager in preparation of contracts with institutions • Mentorship of less experienced colleagues, co-monitoring visits and trainings • Preparation of documents for IRB submissions • Review and SDV of patients' medical files for completeness, accuracy, consistency and compliance • Support of study data queries resolution, AE and SAE Reporting
4 Jahre, Okt. 2004 - Sep. 2008
Research Assistant of Molecular Pharmacology and Radiobiology Department
Russian State Medical University, Moskau, Russland
• Pharmacological research of gestagenic and glucocorticoid steroid impact on intact and pathologically transformed skin fibroblasts • Preparation of reports, presentations, writing scientific articles and reviews for medical journals
Ausbildung von Ariuna Liga
4 Jahre und 1 Monat, Sep. 2005 - Sep. 2009
Molecular Pharmacology and Radiobiology Department
Russian State Medical University
PhD thesis subject: "Pharmacological and biochemical analysis of some steroid hormone derivatives impact on psoriatic and normal skin fibroblasts"
5 Jahre und 10 Monate, Sep. 1999 - Juni 2005
Biomedical Department
Russian State Medical University
Medical Cybernetics, Molecular Pharmacology, General Medicine
Sprachen
Russisch
Muttersprache
Deutsch
Gut
Englisch
Fließend