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Summary

i am a talented and determined Scientist with a sound expertise in the fields of molecular biology, oncology, Cell biology and pre-Clinical Drug Development. i am also passionate about all the innovations in the Biomedical area. throughout my phd and post-doctorate experiences i built up a long standing expertise in team-oriented and international environment and i developed excellent writing, Communication and presentation skills.

Experiences

Current Experience

  • Regulatory Submission Coordinator


    Since January 2016
    • distribute, track, review, and approve individual site trial master file (tmf) essential Documentation at project start • collect, review, organize, and assemble regulatory submissions • maintain timelines for study start-up submissions and all subsequent submissions • provide advice and guidance to internal and external team members to ensure Compliance with applicable regulations and requirements • review pertinent regulations and guides to develop proactive solutions to Clinical Trial submissions issues and challenges • collaborate with document center to ensure necessary Documentation is present • train and assist cras on the collection of essential Documentation for the ongoing phase of the project • Distribute, track, review, and approve individual site trial master file (TMF) essential documentation at project start • Collect, review, organize, and assemble regulatory submissions • Maintain timelines for study start-up submissions and all subsequent submissions • Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements • Review pertinent regulations and guides to develop proactive solutions to clinical trial submissions issues and challenges • Collaborate with document center to ensure necessary documentation is present • Train and assist CRAs on the collection of essential documentation for the ongoing phase of the project

Past Experience

Personality

Self Assessment :
Analytical thinkingAdaptabilityApproachabilityAttention to detailCollaborationIndependenceInterest in knowledgeOrganizationProactivityProblem solvingResponsibilityResult OrientedSelf-confidence

Knowledge

LinkedIn Assessment :
molecular biologyScientific WritingCell biologyResearchCell CultureqRT-PCRsciencemouse modelsWestern BlottingIn VivoMolecular & Cellular BiologyCRISPR/Cas9Molecular CloningLife SciencesLiterature ReviewsIn VitroPCRFluorescence MicroscopyImmunocytochemistryPolymerase Chain Reaction (PCR)

Education

  • PhD in Life and Biomolecular Sciences in Oncology and Cancer Biology from The Open University in 2014
  • Post Graduate Specialization in Pharmacological Research in Oncology and Cancer Biology from Mario Negri Institute for Pharmacological Research in 2010
  • Master of Science (M.Sc.) in Biotechnology from Università degli Studi di Milano-Bicocca in 2008
  • Bachelor of Science (B.Sc.) in Biotechnology from Università degli Studi di Milano-Bicocca in 2005

Languages

BrightOwl Assessment:
Self Assessment:
Italian
Native
English
Full Proficiency
Dutch
Elementary Proficiency

Work Preferences

  • Notice Period:
    4 weeks
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Maastricht, Netherlands

Others

Driving License
  • Yes

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