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Summary

•      Clinical Research Professional with 9 years' experience in Clinical Development in Pharmaceutical/biotech industry, cros and academia
•      expertise area in early Clinical Development: phase 1/2a, proof-of-concept, exploratory Biomarkers, dmpk and ddi studies
•      strong business Communication and Negotiation skills, strengthened by international background and extensive network of scientific, clinical research and business professionals worldwide
•      academic background (m.d. diploma, fellowship in Pathophysiology)

Experiences

Current Experience

  • Manager Business Development


    Since August 2016

    cross-functional position in CRO, specialized in early Clinical Development.
    •      all aspects of acquiring new clients with focus on small to mid-size biotech companies
    •      diligent feasibility process with clinical site teams
    •      all aspects of study start-up, incl. Qualification of clinical sites and vendors, Outsourcing, Budgeting and contracting, study Planning, regulatory process, ip and biosample Logistics
    •      oversight of ongoing trials in terms of milestones, enrollment rates, quality and safety
    •      conduct of corporate Presentations at scientific and business conferences
    •      all aspects of pharma intelligence: Analysis of Clinical Trial data, Publications and conferences, either as contributing to development of poster Presentations and articles
    •      lead for implementation of multi-omics researches into early Clinical Development solutions

    Cross-functional position in CRO, specialized in early clinical development.
    •      All aspects of acquiring new clients with focus on small to mid-size biotech companies
    •      Diligent feasibility process with clinical site teams
    •      All aspects of study start-up, incl. qualification of clinical sites and vendors, outsourcing, budgeting and contracting, study planning, regulatory process, IP and biosample logistics
    •      Oversight of ongoing trials in terms of milestones, enrollment rates, quality and safety
    •      Conduct of corporate presentations at scientific and business conferences
    •      All aspects of pharma intelligence: analysis of clinical trial data, publications and conferences, either as contributing to development of poster presentations and articles
    •      Lead for implementation of multi-omics researches into early clinical development solutions

Past Experience

  • Jr. Early Stage Development Scientist /Sr. CRA Moscow, Russia

    September 2013 --- July 2016

    clinical site monitoring and trial management in phase 1 studies in accordance with ich-gcp, sops and local regulations in multiple countries in europe (proof-of-concept, exploratory Biomarkers, ddi).
    •      oversight of study conduct at country level and oversight of contracted cros, incl. all aspects of regulatory process, ip and biosample Logistics, study reporting, pv, Data Management
    •      review of critical subjects’ data and providing go/no-go decision
    •      ensure study deliverables are met: milestones, enrollment, qc, tmf reconciliation
    •      contributing to development of study protocols, icfs and manuals, either as corporate sops
    •      conduct of Qualification assessment of vendors: Clinical research units, laboratories, pharmacies
    •      development of Training plans and providing trainings to investigators’ teams
    •      general CRA responsibilities
    •      various Therapeutic Areas: Infectious diseases (viral hepatitis), immune-inflammatory diseases, Cardiology, oncology, Hematology

  • Clinical Research Associate (CRA) Moscow, Russia

    February 2011 --- August 2013
    clinical site management and monitoring in Phase II-iii Clinical trials per ich gcp, sops and local regulations in russia. various Therapeutic Areas: immune-inflammatory diseases, Infectious diseases, cardio-metabolic diseases, pulmonology, oncology, Vaccines.

  • Clinical Research Associate (CRA) Barnaul, Altai Krai, Russia

    September 2009 --- January 2011

    clinical site management and monitoring in Phase III-iv Clinical trials for major Pharmaceutical companies in accordance with ich gcp, sponsor sops and local regulations in russia. various Therapeutic Areas: Infectious diseases, Vaccines, pulmonology, oncology.

  • Research Assistant

    September 2008 --- December 2010
    research work in Pathophysiology and cerebral circulation disorders. experience in clinical Pathology and Analytical Chemistry (HPLC) methods of research. experience in various types of ultrasound Diagnostics. experience in animals researches, basic skills in anatomical Pathology. Teaching Pathophysiology to students of the medical University. sub-Investigator in Clinical research studies (Vaccines).

Personality

Self Assessment :
Analytical thinkingCollaborationCommunicativeCompetitivenessEfficiencyFlexibilityIndependenceInnovative thinkingInterest in knowledgeOrganizationProactivityProblem solvingAttention to detailCoordinationCritical thinkingResponsibility

Knowledge

Self Assessment :
Clinical Site ManagementEarly Stage DevelopmentStandard Operating Procedure (SOP)Adverse Events (AE)Quality Control (QC)Essential DocumentsEthics submission and approval processRegulatory submissionsClinical Trial SuppliesContract negotiationHealthcare industryInformed Consent DocumentsPresentation SkillsProtocolQA complianceSafety reportingSerious Adverse Event (SAE)TeamworkVaccines
LinkedIn Assessment :
Clinical Site MonitoringPhase IClinical trialsICH-GCPProof of conceptClinical researchClinical Site ManagementPhase IIPhase IIIViral HepatitisExploratory ResearchAutoimmune DiseasesInfectious diseasesPharmaceutical IndustryCROCTMSEDCDiagnostic UltrasoundFunctional testingPathophysiology

Skills and Expertise

Self Assessment :
Early clinical developmentFeasibility analysis of proposed trial designOutsoursingbusiness developmentAssess site feasibilityCollaborate with principal investigatorCollaborate with project teamSite managementWork with coordination and data management teams Monitor a clinical studyProvide trainingQuality control processbudgeting of R&D activitiesEstablish contractsTrial Management

Education

  • Doctor of Medicine (M.D.) in Medicine from Altai State Medical University in 2010
  • Specialist in Functional and Ultrasound Diagnostics from Altai State Medical University in 2010
  • General Practitioner in Therapy from Altai State Medical University in 2009

Training and Certification

  • GCP Business Practices in 2016 Certification
  • CRA GCP Applied Training in 2014 Certification
  • Early Stage Development Training for CRAs in 2013 Certification
  • Refresher GCP Course in 2011 Certification
  • GSK Advanced Monitoring Course in 2010 Certification
  • General Principles of ICH-GCP for Investigators in 2009 Certification

Languages

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

Work Preferences

  • Positions I am interested in:
    Clinical Project Manager (CPM) Clinical Project Leader associate Clinical Project Manager Global Clinical Project Manager (GCPM, GTM) Clinical Trial Manager (CTM) Clinical Operations Manager Clinical Scientist Licensing Manager Feasibility Manager Outsorcing Manager
  • Locations I am interested in:
    Austria Belgium Czech Republic Denmark Finland France Germany Hungary Ireland Italy Netherlands Norway Poland Slovakia Spain Sweden Switzerland UK
  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl freelancer
    BrightOwl employee
  • International:
    Yes

Area / Region

Düsseldorf, Germany

Others

Driving License
  • Yes

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