Lívia Dr. Belényesi

Recently my role as senior CRA covers wide range of study conduct from pre-feasibility, feasibility, site selection, budget-and contract negotiation, site initiation, interim monitoring visits, close out visits in different studies. I am responsible for several sites in phase3 liver cirrhosis and oncology (breast cancer phase3 and solid tumor phase1) studies.

Expert in the field of Immunology, Autoimmun disorders such Crohn's disease, Psoriasis, Ulcerative Colitis, Rheumatoid Atrhritis. Huge experience and great achievments of management sites with large patient number. Perform site selection, site initiation, interim monitoring and close-out visits of several multicenter studies for Gilead and BMS. System and Vendor experience: CTMS, Veeva, Medidata Rave, ClinPhone, Bioclinica, Covance, Bracket, ERT

Sponsor dedicated CRA for Eli-Lilly. Therapeutic areas: Psoriasis, Oncology (Phase III.), Monitoring experience: Site initiation, Site monitoring, RBM, Audit (oncology), Close out visits, DBL, non compliant site early termination, biomedicines Home based working environment. Special experience: International monitoring (UK, Romania), working exclusively for Eli-Lilly.

Therapeutic areas: Ulcerative colitis, Crohn’s Disease, Psoriasis, DM Type II, Polycistic Kidney Disease, (Phase II-III.). Number of studies: 10, Number of sites: 80. Monitoring experiences: SSV, SIV, SMV, COV, DBL, Investigator payment. Office based-semi home based working environment. Special experience: coordination of study early termination for 11 sites, working for Takeda, Roche, Janssen, Sandoz, working with biological therapy.

Regulatory and Start-up phase of Phase I-IV. clinical trials (Rheumatoid Arthritis, Diabetes, Oncology, Renal Failure): ICF, RA/EC submissions, Contract- and budget negotiations, coordinating essential documents for study start-up, communication with sites. Office based working environments.

Pharmaceutical Care on Metabolic Syndrome Program, general pharmacist tasks.

Start up the Hungarian subsidiary of Vitabalans. Planning: Strategic Business Plans, Marketing Plans, Sales Plans for sales reps. Launch OTCs and food supplements to the Hungarian pharmaceutical market. Training reps. Dealing with wholesalers.Leading small Hungarian team.

Product management of Clinical Nutrition (Parenteral and Enteral Nutrition) medicines and medical devices.KOL management. Creating/presenting marketing plans, keeping lectures for pharmacy students, organizing conferences and meetings, presentations in conferences.

Visiting GPs, Cardiologists, Neurologists, Diabetologists, Hospital Pharmacists with Diaprel, Coaxil, Preductal,Detralex in Budapest. Representation in conferences, organizing meetings and symposia for doctors. Activity planning.

TEMPUS scholarship, I've joined to research group at Department of Pharmaceutical Technology under supervising.

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