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Summary

• CEO & founder of CRA School and Access Pharma Group, providing qualified CTA, CRC and volunteers to academy and industry to speed up the initiation of their clinical research projects through the Access Clinical Research CRO/SMO. • Organizes Pharma Careers Days in Montreal. Next event, Apr.7 at 6:00 pm after PharMed • CRAC Exec Member, Clinical Research Job Insertion Program Coordinator. Passionate mentor & facilitator. Credo: Together, we can ! • The Access Pharma Group includes the Clinical Research Training Center-Montreal, the CRO/SMO Access Clinical Research & the NGO CFRC 'Access Pharma' • Their mission is to accelerate the career transition of highly educated professionals into the clinical trials industry • The unique CRP Certification & Job insertion program provides over 900+ pages CRA+CRC training, unlimited remote internship & coop placement assistance with CV adaptation, interview preparation & analysis for every job, plus mentoring till hire. - Certified CRA, MSc, with 9+ years CRA experience, R&D Consultant, Clinical Research coach. - Over 15 years experience in R&D in Health Care environment and Hospital settings; - Member of the CRAC Montreal Exec Committee, of SoCRA and CAPRA - Deep knowledge of ICH GCP (E6, E2), Declaration of Helsinki & CIOMS regulations, FDA 21 CFR Canada F&D Act Part C, Div. 5, and of the FRSQ & EMA guidelines Specialties: Phase I – IV Clinical Trials, ICH GCP, CVD, Oncology, CNS, Dermatology, Diabetes, ID & Medical Devices. Intra-Oral Dental Products, Immunology, HBV/HCV/HIV & Tumor Markers, Molecular Biology, Respiratory Physiology, Blood gas/Electrolytes, Hematology, Biochemistry, GMP, ISO 9001, 9002, 13485, R&D, GCP, GMP, GLP, GDP High ability to understand complex medical concepts and cope both with scientific & organizational aspects of Drugs and Medical Devices studies. Multilingual team player.

Experiences

Current Experience

  • General Manager, Principal CRA
    Since March 2014
    CEO & Founder of the Access Pharma Group, consisting of 3 non-for-profit organizations: o CRA School of Montreal o Access Clinical Research CRO/SMO o CFRC Access pharma (Cercle de formations et réseautage communautaire), Founder of Access Pharma Group, a joint venture project of organizations having missions to facilitate the career reorientation of highly educted professionals Certified CRA, MSc, 8+ years CRA experience, over 14 years experience in Health Care environment and Hospital settings; MSc in Biomedical Engineering, R&D Consultant Deep knowledge of ICH GCP, FDA/TPD & EMEA regulations Monitoring / managing sites in Phase I – IV Multiceter Trials, Site Initiation, Follow-up and Close-out visits; • ICH GCP (E6, E2) & FDA GCP (21 CFR 312, 21 CFR 56, 21 CFR 50, 21 CFR 54, Form 1572, 45 CFR 46 Common rule, CIOMS), Health Canada regulations, CTSI, QIU, REBA, • Clinical Trial Monitoring Methodology, Site Management and Coordination, • Systematic Monitoring Approach to Effectively Monitor Multi-Center Clinical Trial • IC, SDV, Data management and query resolution, Drug accountability, • Safety and SAE Reporting, ConMed, MediData Rave, InForm, Open Clinica Demonstrated high ability to understand complex medical concepts and to cope both with scientific and organizational aspects of Drugs and Medical Devices studies. Professional demeanour and appearance. Fully operational home office. Multilingual.

  • Executive Board Member
    Since March 2013
    The Clinical Research Association of Canada is a non-profit organization whose mission is to provide a forum for discussion and exchange of ideas relevant to all aspects of clinical research in Canada; CRAC provides its' members with a uniquely Canadian perspective designed to serve the needs of Canadian clinical research professionals and provide Canadian recognition with the Clinical Research Professional of Canada certification; Regular dinner meetings offer members the opportunity to network with other clinical research professionals, and hear from industry experts on hot topics facing our industry;

  • Director, Coordinator of the Clinical Research Job Insertion Program
    Since September 2010
    Founder of the Center for Community Trainings and Networking in NDG, Montreal, a non-for-profit organization with the mission to facilitate the professional integration of highly educated specialists, trained abroad in the field of clinical research and regulatory affairs Pro-bono Coordinator of the Clinical Research Job Insertion Program, mentor, runs free weekly consultations on the social and professional integration of qualified specialists, trained out of Canada The Center is member of the Access Clinical Research Group

Past Experience

  • Coordinator, Job Insertion Program
    January 2012 --- January 2015
    Organizing networking events with pharmaceutical companies to present the different career opportunities in regulatory affairs to newcomers and highly educated professionals in career change

  • General Manager, Principal CRA
    November 2012 --- March 2014
    Founder of the Contract Research Organization (CRO) 'Access Clinical Research', associated to CRA School. It has been created to give access to additional patients for the CROs and pharmaceutical companies and provide experienced coordinators to sites with detailed, GCP-compliant SOPs and full organizational support as well as GCP training and support to qualified physicians-investigators, interested to participate in clinical trials The main objective of the CRO is to identify physicians who presently do not participate in clinical trials as Investigators but have patients who would qualify for different studies. Feasibility studies are run free of charge upon a Sponsor's request

  • Executive Manager and Independent CRA Consultant
    November 2009 --- October 2012
    CEO and founder of the Clinical Research Training Center of Montreal, an international provider of international Clinical Research Education and Professional Certification. Developed an unique combined program of Regulatory Training, unlimited Internship and 7/7 Job Placement Support till hire for medical or life science professionals, interested to change careers and enter into the rewarding field of clinical trial administration and management.

  • Clinical Research Associate, CRA
    March 2008 --- October 2009
    • CCRA , MSc, Developed an on-line CRA Training course for professionals in career reorientation Monitoring / managing sites in Phase I – IV Multiceter Trials, Site Initiation, Follow-up and Close-out visits; • ICH GCP (E6, E2) & FDA GCP (21 CFR 312, 21 CFR 56, 21 CFR 50, 21 CFR 54, Form 1572 45 CFR 46 Common rule, CIOMS), CTSI, QIU, REBA, DSA • Clinical Trial Monitoring Methodology, Site Management and Coordination, • Systematic Monitoring Approach to Effectively Monitor Multi-Center Clinical Trial • IC, SDV, Data management and query resolution, Drug accountability, • Safety and SAE Reporting, ConMed, MediData Rave, InForm, Open Clinica Demonstrated high ability to understand complex medical concepts and to cope both with scientific and organizational aspects of Drugs and Medical Devices studies. Professional demeanour and appearance. Multilingual.

  • New Products Manager
    February 2000 --- February 2008
    Member of the New Products Design Team and & R&D Consultant; Participated in the R & D of the new products. Provided Technical Support for Intra-Oral Dental Materials and Dental Medical Devices

  • Branch Manager, Hospital Equipment and Supplies
    October 1993 --- September 1999
    Sales Rep and Manager of the Bulgarian Branch, distributor of Nova Biomedical, Dynatech Instruments, Life Science International, Greiner Labortechnic, sub-dealer of Fucuda Denshi, Elscint, Aesculap and others. Won several international tenders, awarded as Sales Rep #1 Internationnaly by Skalar BV

  • CRA / Clinical Trial Monitor, Bulgarian Branch
    October 1997 --- January 1999
    Field monitor in Drugs and Medical Devices Clinical Trials Trained CRA, 1,5 years CRA experience, over 5 years experience in Health Care environment and Hospital settings; BSc in Bio-medical Engineering Deep knowledge of EMEA clinical trial regulations Monitoring / managing sites in Phase II – IV Multicenter Trials, Site Initiation, Follow-up and Close-out visits; • Clinical Trial Monitoring Methodology, Site Management and Coordination, • Systematic Monitoring Approach to Effectively Monitor Multi-Center Clinical Trial • IC, SDV, Data management and query resolution, Drug accountability, • Safety and SAE Reporting, ConMed, MediData Rave, InForm, Open Clinica Demonstrated high ability to understand complex medical concepts and to cope both with scientific and organizational aspects of Drugs and Medical Devices studies. Professional demeanour and appearance. Multilingual.

  • Product Sales Manager, Laboratory Equipment
    December 1989 --- September 1993
    Sales rep of Technicon GmbH/Bayer Diagnostics - Austria, Medical Devices manufacturer

  • Research Fellow, Analytical Instruments
    June 1987 --- December 1989
    Research Fellow in the Analytical Instruments dept, Gas Chromatography and Water Quality Analysis

Knowledge

LinkedIn Assessment :
ICH GCP21 CRFFDA Health Canada EMEA45 CRFClinical researchClinical monitoringClinical DevelopmentClinical trialsClinical trial managementEDCSOP21 CFR Part 11ICH-GCPR&DGCPCROClinical Data ManagementRegulatory submissionsPharmaceuticalsMedical DevicesRegulatory affairsTherapeutic AreasCardiologyHypertensiononcologyInfectious diseasesDiabetesImmunologyEndocrinologymolecular biologyDermatologyNeurologyHematologyCancerGLPBiotechnologyPharmacovigilanceLife SciencesBiomedical EngineeringCathetersEKGSOPPharmaceutical IndustryDrug DevelopmentInformGMPProtocolBiopharmaceuticals

Education

  • CCRA in CRA from Clinical Research Certification Program, KRC International, Toronto in 2007
  • Post-Graduate Studies in Post-Graduate Studies in Management & Marketing from DESS in Marketing & Management, National Academy of Economics in 1999
  • Clinical Trials Monitoring in Certificate from Bayer Diagnostics / Technicon in 1993
  • MSC in Biomedical Engineering from Technical University Sofia in 1987
  • in Lycée français from Жизнена школа НРБ in 0
  • DPS in Marketing and Management of SME in from SAJE in 0

Training and Certification

  • PSA, SMB Management and Marketing Certification

Area / Region

Montreal, QC, Canada

Others

Driving License
  • Yes