LAJOS UTCA **-**, I/*/** . **** Budapest. Hungary
Tel.: +36 (06) 30.39.34.089 . E-mail: ******@*****.***
Mirabela alina ponczi
Organizational and leadership skills, background in life sciences degrees,
clinical trial experience; open to new challenges and opportunities for a
solid career growth into clinical research.
Work experience
2008-pres Country Start-Up Specialist at a multi-national leading
ent CRO, PRA Intl.,Hungary
Managing and leading clinical teams in all aspects of the
Clinical Start-Up activities in order to achieve
successful activation of the sites in accordance with
ICH-GCP and all applicable sponsor and regulatory
requirements: implement all start-up methodologies,
overseeing feasibilities, PSSV/SIV planning and
completion, projections, submissions, approvals, essential
documents, contracts and budget evaluation and
2007-pres preparation; ownership of the timelines towards sites
ent initiation, proactive problem/risks identification and
solving. Supervision and training of the clinical staff
and reporting directly to project managers
Countries resposibilities: Romania, Moldova, Bulgaria,
Hungary, Czech Republic, Slovakia
2004-2007 Clinical Research Associate (Field and In-House) at a
multi-national leading CRO, PRA Intl., Hungary
Ensure the trials are conducted in accordance with the
client protocol, local regulatory and IRB/IEC
requirements, standard operating procedures (SOPs),
ICH-GCP guidelines; Performing investigative site
Ian-Jun recruitment/feasibility; Assisting with the preparation
2000 and organization of investigator and study site materials
both at a local and international level; Essential
document collection, review, tracking and maintenance;
Performing Ethics and Regulatory submissions; Preparation
of IP release packages; Initiation, Monitoring and
Close-Out of clinical trials
Therapeutic areas: CNS, oncology; autoimmune disorders,
hemotology, pediatric studies
Assistant Manager at Toro Dorado restaurant, Spuistraat
B.V., The Netherlands
Recruited, trained and supervised more than 10 employees
in this restaurant with 500,000 in annual sales. Helped
to manage payroll, as well as kept track of inventory and
sales figures. Waitressing and improving/maintaining
customer relationships, promoting the restaurant at
different hotels and international events.
Sale consultant of "Oriflame" skin-care and cosmetic
products, Romania
Direct selling of products with the opportunity of
networking and growing the own budget. In a period of 4
months, I raised my own income with approx. 30%. I
learned how to recruit and coached individuals into my
selling consultants group.
EDUCATION
Master in Pharmaceutical Sciences
2004-2007 Vrije University Amsterdam, The Netherlands
Advanced English-taught program based on research in the
area of drug discovery and development, including
internships and theoretical courses related to science and
management. Tackled case studies and assignments in groups
or individually.
Compulsory components included courses like Principles of
Pharmaceutical Sciences/Pharmacochemistry, Molecular
Pharmacology and Molecular Toxicology of Drugs, Concepts
and Experimental Approaches in Drug Toxicity, Drug
Disposition & Safety Assessment, Receptor Structure and
Function, Pharmacodynamics of Drug Action, Biochemical
Mechanisms of Toxicity and Immunity. In summary, the
courses discussed methods of drug discovery, drug design,
drug development and drug safety assessment, potential
drug targets, molecular aspects of the mechanisms by which
drugs act with respect to their therapeutic application
(including drug-receptor/enzyme interactions and
dose-response relations), drug disposition (including
1998-2003 pharmaco-/toxicokinetics).
Bachelor in Biochemical Engineering
Babes-Bolyai University Cluj-Napoca, Romania
Multidisciplinary studies regarding the (bio)chemical
processes involved in different industries:
pharmaceuticals, cosmetics, beer and alcohol, environment,
etc. Technological processes and industrial economy were
part of the program, as well.
grants received
2005 Rutgers Scholarship (Vrije University, The Netherlands)
Competitive award that recognizes and encourages academic
excellence; criterias of selection included academic
2004 achievement, leadership qualities and potential for
success.
Huygens Scholarship (Nuffic Organization, The Netherlands)
2002
Competitive dutch award for the top 10% of master students
in their study programme, with excellent results in all
previous studies
Socrates-Erasmus Scholarship (Babes-Bolyai University,
Romania)
European student exchange programme which enabled me to
live abroad for the first time; it was a multicultural and
multilingual experience in creating the so-called
pan-European identity.
Trainings and internships
2006 Internship at ORGANON/SCHERING-PLOUGH pharmaceutical co.
Industrial project within the Molecular Pharmacology
department of the company with interest in immunologic
therapeutic area. Results obtained raised further interest
and positively impacted the company's general project.
2003 Training in Beer Industry: Silva S.A., Reghin, Romania
2002 Training in Chemical Industry: Oltchim, Ramnicu-Valcea,
2001 Romania
2001 Training in Cosmetic Industry: Farmec S.A., Cluj-Napoca,
Romania
Training in Pharmaceutical Industry: Terapia S.A.,
Cluj-Napoca, Romania
extracurricular activities
2001 Model in "Freestyle" modeling agency, Romania
Gained extra self confidence, reliability and discipline.
2000-2002 Vice-chairman of Chemical Student Organization, Romania
Attended group meetings with the faculty's board of
directors concerning the rights of students, implicated in
taking decisions, mentored 3 first-year students;
organizing member of 2001 edition Symposium within the
Chemistry Faculty, member of Student Scholarships,
1999-2000 Accommodation and Hostel Committees, "Greenhorn Ball"
organizer for the 1st year students; funds collecting
experience for student festivals, parties.
Actress in "Gaudeamus" student theatre troupe, Romania
Maintained stamina and control of the situation.
Computer skills
Operating systems: Windows 2000, Windows XP
Programming Languages: Matlab 6.0 (basic), Visual C++
(basic)
Software knowledge: MS Office 2000: Excel, Word,
PowerPoint, MOE, Prism,
ChemDraw, Chemcad, CTMS, eTMF
Language Knowledge
Romanian: native language
English and Hungarian: fluent in speaking, reading and
writing
Dutch: conversational level, good in reading and writing;
courses taken during the master program at Vrije
Universiteit; several interviews and presentation
conducted in Dutch
French, Spanish, Italian, German: basics and improving
interests
Traveling, Philosophy, Fashion, Sport, Music
Signature:
Date:
04-Mar-2011