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Summary

three years experience in cinical trial management in romania, study monitoring, Quality Assurance, Biostatistics, site management, SOP Editing, writing, Regulatory Affairs. more than 7 years experience in sales and Sales Management. powerfull expertise in people management, territory and Business Planning Analytical Skills. capability to administrate people, projects and Budgets, especially in the field of Clinical trials. 3 years experience in Clinical trials, and 2 years experience in bioequivalence trials. sense of organization with a 3 year experience in Logistics as: implementing and finalizing SOP, hrd projects, launching a CRO company, authorization and certification of a Clinical Trial site.good experience in project and team management acquired trough work. good command of Quality Control processes and Quality Management in Clinical trials. MD, phd in Medicine.

Experiences

Current Experience

  • Study Physician


    Since October 2014

    ▪    study Physician tasks (Cardiology, oncology, Diabetes, copd, Vascular Medicine, anemia)

    ▫    improvement of the medical review plan

    ▫    review and amendment of study science)" rel="nofollow">Protocol, and other study specific documents

    ▫    scientific article writing, finding relevant literature, evaluation of relevant literature, quality check of an already written article.

    ▫    creation of presentation (ppt), poster creation, quality check of an already created ppt presentation or poster.

    ▪    safety/ medical monitoring and medical review of data (oncology, copd)

    ▫    patient profile review

    ▫    sae/ae listing review, evaluation of hidden saes, query raising

    ▫    trend review of study data: ae frequency review, disease progression review, safety evaluation of study specific data, subject disposition review, vital sign review, Lab listing review, pdv evaluation and frequency, imp administration review, other study specific tasks

    ▪    science)" rel="nofollow">Protocol writing: based on a given template and on pre-Clinical and Clinical data available. finding relevant literature.

    ▪    safety reporting

    ▪    narrative writing based on cioms and data listings. (cardio-Vascular diseases)

    ▪    narrative review: quality check and query raising for already written narratives. (oncology)

    ▪    contact with investigators

    ▪    contact with authorities

    ▪    Phase I studies

    ▪    Phase II/iii studies

    CRA

    ▪    Study physician tasks (cardiology, oncology, diabetes, COPD, vascular medicine, anemia)

    ▫    Improvement of the medical review plan

    ▫    Review and amendment of study protocol, and other study specific documents

    ▫    Scientific article writing, finding relevant literature, evaluation of relevant literature, quality check of an already written article.

    ▫    Creation of presentation (PPT), poster creation, quality check of an already created PPT presentation or poster.

    ▪    Safety/ medical monitoring and Medical review of data (oncology, COPD)

    ▫    Patient profile review

    ▫    SAE/AE listing review, evaluation of hidden SAEs, query raising

    ▫    Trend review of study data: AE frequency review, Disease progression review, safety evaluation of study specific data, Subject disposition review, Vital sign review, Lab listing review, PDV evaluation and frequency, IMP administration review, other study specific tasks

    ▪    Protocol writing: based on a given template and on pre-clinical and clinical data available. Finding relevant literature.

    ▪    Safety reporting

    ▪    Narrative writing based on CIOMS and data listings. (cardio-vascular diseases)

    ▪    Narrative review: quality check and query raising for already written narratives. (oncology)

    ▪    Contact with investigators

    ▪    Contact with Authorities

    ▪    Phase I studies

    ▪    Phase II/III studies

    CRA

  • Partner


    Since January 2014
    Clinical trials / Clinical Trial services / bioequivalence medical review Medical writing Data Management pharmacokinetic evaluation of the test substance, and bioequivalence trial design science)" rel="nofollow">Protocol writing Investigator’s brochure writing crf preparation subject information leaflet, and Informed Consent preparation study approval, and dossier management study insurance management study monitoring pharmacokinetic and pharmacodynamic evaluation of the results (Statistics) – Statistical report final report preparation Clinical Trial monitoring Clinical Trials / Clinical Trial Services / Bioequivalence Medical review Medical writing Data management Pharmacokinetic evaluation of the test substance, and bioequivalence trial design Protocol writing Investigator’s Brochure writing CRF preparation Subject information leaflet, and informed consent preparation Study approval, and dossier management Study insurance management Study monitoring Pharmacokinetic and Pharmacodynamic evaluation of the results (statistics) – Statistical report Final report preparation Clinical trial monitoring

  • Internal Medicine Specialist (physician) - Investigator

    Tirgu Mures (Romania)
    Since November 2010

    ▪    Investigator (Phase II and iii studies - Internal medicine, Gastroenterology, pulmonology, Vascular medicine, Immunology and Hematology)

    ▪    study management (as subinvestigator - on site coordination of the study - Informed Consent, visit schedule, ivrs reports, crf completion, answering queries).

    ▪    vendor management

    ▪    Medical writing - scientific article writing, Publications, finding relevant literature, presentation

    ▪    contact with kol

    ▪    Internal medicine - board certified Internal medicine Physician:

    ▫    skills:

    ▪    specialization in Internal medicine

    ▪    capability in diagnosing conditions affecting the internal organs

    ▪    excellence in treating patients confined for a variety of Internal medicine problems

    ▪    expertise in reading and interpreting Laboratory results (ecg, 2d echo, doppler studies, etc) and utilizing them in patient Treatment

    ▪    commendable assessment skills

    ▪    ability to work well and maintain composure even under extreme pressure

    ▪    ability to work harmoniously with fellow physicians, nurses, Pharmacists, and other Hospital personnel

    ▪    excellent Communication Skills

    ▪    close attention to details

    ▪    interest in conducting researches for the improvement of patient care

    ▫    responsibilities

    ▪    to treat adult patients with the following conditions: Cardiology, pulmonology, Gastroenterology, Hematology, Vascular diseases, Immunology etc

    ▪    to diagnose other patients with Internal medicine conditions

    ▪    to perform abdominal ultrasound examinations

    ▪    to prescribe medications to patients to treat their illnesses and conditions

    ▪    to order procedures for the immediate diagnosis needed for Treatment

    ▪    to interpret and correlated Laboratory results to suit the patient's needs

    ▪    to conduct rounds to monitor patient progress and recovery

    ▪    to reffere patients to other medical specialists for other needed interventions

    ▪    to oversaw the performance of newly-certified Internal medicine Physician

    ▪    in the field of Vascular medicine, and autoimmune diseases:

    ▪    Vascular ultrasound examinations: carotid artery evaluation, abdominal vessels ultrasound, peripheral arterial diseases (atherosclerosis, tromboangiitis obliterans), raynaud's disease, progressive systemic sclerosis and other immune Vascular diseases.

    ▪    performed peripheral arteriography

    ▪    performed laser doppler flowmetry - for evaluation of microcirculatory diseases

    performed pulse wave velocity evaluation - as part of a Research

    ▪    Investigator (phase II and III studies - internal medicine, gastroenterology, pulmonology, vascular medicine, immunology and hematology)

    ▪    Study Management (as subinvestigator - on site coordination of the study - informed consent, visit schedule, IVRS reports, CRF completion, answering queries).

    ▪    Vendor Management

    ▪    Medical writing - scientific article writing, publications, finding relevant literature, presentation

    ▪    Contact with KOL

    ▪    Internal Medicine - Board Certified Internal Medicine Physician:

    ▫    Skills:

    ▪    Specialization in Internal Medicine

    ▪    Capability in diagnosing conditions affecting the internal organs

    ▪    Excellence in treating patients confined for a variety of internal medicine problems

    ▪    Expertise in reading and interpreting laboratory results (ECG, 2D Echo, Doppler Studies, etc) and utilizing them in patient treatment

    ▪    Commendable assessment skills

    ▪    Ability to work well and maintain composure even under extreme pressure

    ▪    Ability to work harmoniously with fellow physicians, nurses, pharmacists, and other hospital personnel

    ▪    Excellent communication skills

    ▪    Close attention to details

    ▪    Interest in conducting researches for the improvement of patient care

    ▫    Responsibilities

    ▪    To treat adult patients with the following conditions: Cardiology, Pulmonology, Gastroenterology, Hematology, Vascular Diseases, Immunology etc

    ▪    To diagnose other patients with Internal Medicine Conditions

    ▪    To perform Abdominal Ultrasound examinations

    ▪    To prescribe medications to patients to treat their illnesses and conditions

    ▪    To order procedures for the immediate diagnosis needed for treatment

    ▪    To interpret and correlated laboratory results to suit the patient's needs

    ▪    To conduct rounds to monitor patient progress and recovery

    ▪    To reffere patients to other medical specialists for other needed interventions

    ▪    To oversaw the performance of newly-certified Internal Medicine Physician

    ▪    In the field of Vascular Medicine, and Autoimmune diseases:

    ▪    Vascular ultrasound examinations: carotid artery evaluation, abdominal vessels ultrasound, peripheral arterial diseases (atherosclerosis, tromboangiitis obliterans), Raynaud's disease, Progressive systemic Sclerosis and other immune vascular diseases.

    ▪    Performed peripheral arteriography

    ▪    performed Laser Doppler Flowmetry - for evaluation of microcirculatory diseases

    Performed Pulse Wave Velocity evaluation - as part of a research

  • Associate of Professor


    Since March 2005
    Associate of Professor at 2nd medical department. ▪ Teaching semiology. ▪ Teaching Internal medicine. ▪ science and Publications. ▪ Presentations, conferences, meetings. ▪ invited speaker at symposiums, and conferences about Clinical trials, Compliance to gcp and local regulation Associate of Professor at 2nd Medical Department. ▪ Teaching semiology. ▪ Teaching internal medicine. ▪ Science and publications. ▪ Presentations, conferences, meetings. ▪ Invited speaker at symposiums, and conferences about clinical trials, compliance to GCP and local regulation

Past Experience

  • CEO

    September 2011 --- January 2014
    Director and chief executive vim spectrum - clinical and analytical research center, corunca (romania) vim spectrum is a generic drug Manufacturing company, with a clinical and analytical research center. as CEO of this center, the main activities and responsabilities were: organizing and starting the Clinical research center. building and starting an emea compliant Quality Assurance system. SOP writing, Compliance with the eu/emea legislation, Compliance with local legislation (nammd), cpmpliance with gcp, glp, ich. Recruiting and Teaching a competitive team. searching, choosing, and attracting proper investigators for the trials conducted. finding nurses, Teaching and preparing them for studies. finding suppliers, contracting, Auditing suppliers. attract possible partners and bringing trials to the center. trial feasibility. trial Logistics. Medical writing. science)" rel="nofollow">Protocol writing, Informed Consent, Investigator's brochure, crf compiling, preparing dossier for submitting the study to iec and national regulatory (nammd). eudra ct submission. study Director for performed trials. Biostatistics, for the performed trials. pk report, final report. compiling Investigator's dossier, and submitting the final report to iec, and nammd. leading Internal Audit, external audit. for the factory: Human Resources - job Applications, leading the interview. creation of an Employee accountability system. creation of a useful Marketing tool, for the factory, which can follow the Sales, the production, and can calculate the target for the company and for the employees too. these roles are only a few, from the whole list of roles, covered by me in vim spectrum.

Personality

Self Assessment :
Analytical thinkingAttention to detailAuthenticityCollaborationCritical thinkingCreative thinkingCommunicativeEfficiencyIndependenceIndividualityInnovative thinkingInterest in knowledgeOrganizationProactivityStrategic thinkingProblem solvingResult OrientedSelf-confidenceResponsibility

Knowledge

LinkedIn Assessment :
Clinical researchClinical trialsLifesciencesClinical DevelopmentMedical writingPharmaceutical IndustryHealthcareCTMSMedicineInternal medicineClinical pharmacologyStatistical Data AnalysisClinical Data ManagementStrategic PlanningBusiness StrategyMarketing StrategySales ManagementProject ManagementTeam BuildingNegotiationMarketingTeam LeadershipClinical monitoringClinical Site ManagementACRPStudy ManagersDrug AccountabilityRandomizationStatistical Analysis PlansClinical PracticesProtocol ReviewProtocol DesigningBioequivalenceBA/BE studiesAnalytical SkillsTrial ManagementCRORegulatory affairsTherapeutic AreasGCPSOPmanagementoncologyBiotechnologyMedical DevicesQuality Assurance (QA)Good Laboratory Practice (GLP)New Business DevelopmentPharmacovigilanceResearch

Skills and Expertise

Self Assessment :
Analyze data Assure medical quality Control data Develop clinical trial protocols Guide students Interact with physicians Interpret data Monitor a clinical study Report data Write papersAdverse event reportingAdvise on medical perspectivesAnalyze dataApprove queriesLiaise with doctorsLiaise with research teamWritten presentationVerify data

Education

  • Doctor of Philosophy (Ph.D.) in Internal Medicine from University of Medicine and Pharmacy Tirgu Mures in 2002

Training and Certification

  • Pedagogy in 2011 Certification
  • Board certified Internal Medicine Specialist in 2010 Certification
  • GCP in 0000 Certification
  • GCP certification in 0000 Certification
  • GCP online in 0000 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Hungarian
Native
English
Full Proficiency
German
Elementary Proficiency

Work Preferences

  • Notice Period:
    4 weeks
  • Positions I am interested in:
    Clinical Research Consultant Clinical Data Reviewer Clinical Safety Associate Clinical Research Physician Medical Advisor Medical Science Liaison (MSL)
  • Work From Home:
    No
  • Work Regime:
    BrightOwl freelancer :    40 Hours per week
  • International:
    Yes

Area / Region

Romania

Others

Driving License
  • No

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