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Summary

Clinical Data Management, writing DMP DVP, eCRF set up, SAS programming (Edit Checks), Oracle Clinical, Medical Coding, SAE reconciliation, CDISC STDM (ver 3.1.3 e 3.2), Statistics. ISO9001:2008, Quality Management, Quality Assurance, Internal Auditing

Experiences

Current Experience

  • Clinical data manager
    Since April 2015

Past Experience

  • Quality Manager Jr
    August 2014 --- April 2015

  • Project Manager
    May 2014 --- April 2015

  • Clinical data manager
    July 2012 --- April 2015

  • Clinical data manager
    May 2012 --- July 2012

  • Data Manager and Researcher
    October 2010 --- April 2012

  • Stage/Trainee
    December 2009 --- October 2010

  • Doctoral Stage
    September 2008 --- March 2009
    Doctoral Stage c/o Laboratory of Molecular Biology

Personality

Self Assessment :
AdaptabilityCollaborationCompetitivenessCuriosityPerspectiveProblem solvingResiliencyResponsibilitySelf-disciplineStrategic thinkingTrustWillingness to compromiseApproachabilityAuthenticityCoordinationEfficiencyIndependenceKindness

Knowledge

LinkedIn Assessment :
Clinical Data ManagementClinical researchCDISCClinical trialsCROGCPPubMedCochrane LibraryOpenClinicaSASMicrosoft OfficePhotoshopProShow ProducerMS Projectoncologymolecular biologyGestione dei dati cliniciSperimentazioni clinicheBuona pratica clinicaSviluppo clinicoOncologíaBiologia molecolareRicerca clinicaScienze naturaliCTMSIndustria FarmacéuticaICH-GCPBiotecnologíaOracle Clinical

Skills and Expertise

Self Assessment :
Analyze data Build and manage the Trial Master File (TMF) Control data Create SOPs Design case record forms Develop clinical trial protocols Interact with physicians Report dataAdvise on strategyApprove queriesArchive documentationAssess adverse reactionsAttend seminars, courses and meetings within and outside the companyCalculate timelines for conducting and completing the trialClinical data collectioncollaborate in research projects at universitiesCollaborate with medical teamCollaborate with principal investigatorCollaborate with project teamCollect dataCommunicationComplete case report form (CRF)Conduct limited data and/or statistical analysis.Conduct literature searchesConduct literature searches.Conduct post-marketing surveillance studyCoordinationCreate clinical project documents according to the protocolCreate SOPsData codingData entryData miningData validationData verificationDesign case record form (CRF)Design clinical presentationDesign data collection systemsDesign data reporting systemsDesign database Design efficiency studyDesign exclusion criteriaDesign inclusion criteriaDesign clinical trialDesign protocolDesign post-marketing surveillance studyDevelop study budgetDevelop study timelinesDevelop study metricsDocument data reporting systemsDocument data collection systemEnsure consistency between the protocol and CRFEnsure data consistencyEnsure data integrityEnsure good clinical practice (GCP)Extrapolate dataIdentify sitesImplement data collection systemImplement data reporting systemsInteract with computer specialistsInteract with CROsInteract with KOLInteract with nursesInteract with physiciansInteract with pre-clinical scientistsInterpret dataInterpret analytical resultsInteract with statisticiansInterpret scientific dataInterpret research resultsLead teamsLiaise with research team in order to accurately collect and record dataManage Clinical Trial Management System (CTMS) Manage data collection systemManage data reporting systemsmanaging a small teamMonitor dataPeople managementPresent data at congressResolves queriesReview clinical study reportsReview data interpretationReview exclusion criteriaReview inclusion criteriaReview medical reportsReview protocolsReview queriesSerious Adverse Event (SAE) ReconciliationSet up a clinical studySolve problemsTeachingValidate dataVerify dataWork with coordination and data management teamsWork under specific instructionsWork cross-functionallyWork collaboratively with the other members of the clinical research team Write documents

Education

  • Master in Clinical Research in from Università degli Studi di Milano in 2010
  • Bachelor of Science (B.Sc.) in Biology in from Università degli Studi di Milano in 2009
  • High School Degree (in classics studies) - Diploma di Maturità Classica in from Liceo Classico Giosuè Carducci in 2003

Training and Certification

  • Attestato di partecipazione workshop: “Viaggio nella sperimentazione clinica: approfondimenti pratici e applicativi”. (idoneo ai fini del raggiungimento di dieci giornate di aggiornamento obbligatorie previste dal DM 279 del 31/3/2008) Certification
  • Attestato di partecipazione: Corso “Business Behaviour” - 56 ore (Elementi di Comuicazione sul Lavoro, Rapporto di Lavoro, Elementi di Giuslavoro, Sicurezza sul Posto di Lavoro D. Lgs 81/2008, ex 626/94) Certification
  • Attestato di Partecipazione: Giornata Internazionale dell Ricerca Clinica - Clinical Day Quinta Edizione "Quale Ricerca Per Quale Salute?" Certification
  • Auditor Interno di Sistemi di Gestione Qualità (ISO 9001:2008) Certification
  • Certificazione ECDL (European Computer Driving Licence) Certification
  • Good Clinical Practice Training Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Professional Proficiency
Italian
Native

Work Preferences

  • Notice Period:
    4 weeks
  • Positions I am interested in:
    Clinical Data Manager (DM) Data Manager Global Data Manager Clinical Operations Manager Clinical Research Coordinator
  • Positions I am NOT interested in:
    Clinical Research Associate (CRA)
  • Locations I am interested in:
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    No

Area / Region

Milan, Italy

Others

Driving License
  • No