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Experiences

Current Experience

  • CRA/CTL

    Finland
    Since April 2010

Past Experience

  • Manager Clinical Operations Finland

    May 2008 --- March 2010

  • Sr. CRA Finland

    January 2004 --- April 2007

  • Teacher

    August 2003 --- May 2005

  • Clinical Research Associate (CRA) Finland

    June 1998 --- January 2004

  • Clinical Research Nurse Finland

    January 1991 --- June 1998

Personality

Self Assessment :
Attention to detailCollaborationCompetitivenessAuthenticityCommunicativeCoordinationCuriosityEfficiencyFlexibilityCritical thinkingIndependenceKindnessAdaptabilityOptimismInterest in knowledgeResponsibilitySociabilityTrustWillingness to compromise

Knowledge

Self Assessment :
Negotiation R&DCardiologyBudget NegotiationCardiovascular diseasesClinical operationsClinical monitoringClinical trial audits and inspectionsClinical trialsClinical trial managementContract negotiationData cleaningDesigning case report formsEDCElectronic Data Capture (EDC) EnglishGood Clinical Practice (GCP)GynecologyHospitalsEthics submission and approval processICH GCP guidelinesPhase IIPhase IIIPhase IVPrinciples and ethics of clinical researchRegulatory RequirementsRandomization and blindingRandomization SystemsRegulatory affairsRegulatory submissionsSerious Adverse Event (SAE)

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF) Create SOPs Design case record forms Interact with physicians Guide students Monitor a clinical study Write papersAdverse event reportingAdministrative supportApprove consent documents Interact with nursesAdjust processes and methodsAdminister supply requestApprove drug supply Approve Label Master SheetApprove monitoring reportsApprove patient informationApprove queriesArchive documentationArchive study documentsAssess site feasibilityAssign activitiesAssist study siteAttend investigator meetingBuild trial master file (TMF)Capture data on source documentsClinical data collectionCollaborate with medical teamCollaborate with principal investigatorCollaborate with project teamconduct monitor visitsComplete case report form (CRF)Collect patient forms and questionnairesConduct close-out visitsCommunicate with investigatorConduct site initiationConfirm protocol complianceCommunicate with sponsorCreate study documentsDesign case record form (CRF)Contact potential subjectsData verificationData entryDesign subject consent formEnsure good clinical practice (GCP)Ensure data consistencyEnsure data integrityEthics committee applicationEthics committee submissionsFeasibility analysis of proposed trial designFollow-up of external auditsFollow-up of internal auditsFollow-up of quality assurance activitiesGenerate regulatory submissions Indentify clinicians to conduct clinical trialsIdentify investigatorsIndentify sitesInformed consent processInitiation visitInteract with ethics committeeInteract with physiciansInteract with pharmacistsInteract with nursesLabeling compliance with local regulationsmanaging a small teamMonitor a clinical studyMonitor clinical trials Monitoring enrolmentMonitoring subject complianceNegotiate budget Regulatory submissionsReview monitoring reportsResolves queriesRespond to audit findingsRetrieve study documentsReview queriesRegulatory documentationSchedule trial visitsScheduling trial visitsSelect investigatorsSite managementSolve problemsSupervise clinical monitorsStudy-related documentsTrain on site staffTranslate clinical research concepts into specific objectivesVerify dataTrain off site staffWrite papersWriting regulatory documents

Education

  • master in Health Sciences from University of Turku in 2001

Languages

BrightOwl Assessment:
Self Assessment:
Finnish
Native
English
Full Proficiency
Swedish
Elementary Proficiency

Work Preferences

  • Notice Period:
    4 weeks
  • Positions I am interested in:
    Clinical Operations Manager Team Leader Clinical Research Manager Clinical Research Associate Sr. Clinical Research Associate
  • Locations I am interested in:
    Finland
  • Work From Home:
    Yes, 0 to 4 days per week
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Finland

Others

Driving License
  • Yes

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