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Experiences

Current Experience

  • Clinical Trial Manager


    Since August 2010
    -do-ability and feasibility for Hematology/oncology studies - managing studies within oncology/Hematology from start up to close out - team Leader for study teams (site managers & ctas) - support study teams in trial implementation and execution - accompanied site visits to ensure high quality - budget responsibility - co-operation with medical affairs and Marketing departments -Do-ability and feasibility for hematology/oncology studies - Managing studies within oncology/hematology from start up to close out - Team leader for study teams (site managers & CTAs) - Support study teams in trial implementation and execution - Accompanied site visits to ensure high quality - Budget responsibility - Co-operation with Medical Affairs and Marketing departments

Past Experience

  • Senior Clinical Research Associate

    January 2006 --- January 2010
    - do-ability and feasibility for studies in the nordic region - managing studies from start up to close out, incl. submissions - responsibility for oncology studies within the nordic countries - part of a global trial team, representing local trial managers and cras - support for all current and planned projects within the nordic countries - oversight of cros and co-monitoring with cras - mentor for junior cras - Member of team developing eCRF for oncology studies - co-operation with Marketing departments

  • Clinical Research Associate (CRA)

    January 2002 --- January 2005
    - do-ability and feasibility for oncology studies in the nordic region in order to identify investigators and sites - managing set up to close out of Clinical studies - submissions to authorites and Ethics committées - monitoring oncology studies in the nordic countries

  • Medical/Clinical trial assistant

    August 1991 --- December 2001
    - supporting Medical Director and cras - inhouse monitoring

  • Marketing assistant

    January 1987 --- May 1990
    - supporting Marketing Director and Sales personnell - responsibility for event- and conferences

  • Medical secretary

    January 1981 --- January 1984

Personality

Self Assessment :
FlexibilityProblem solvingResponsibilitySelf-confidenceCuriosityTrustService orientedResult OrientedAdaptabilityCollaborationInterest in knowledge

Knowledge

Self Assessment :
R&D NegotiationAntibodiesCancerBudget ManagementBudget NegotiationCAPAClinical DevelopmentClinical monitoringClinical operationsClinical researchClinical trial audits and inspectionsBudget ProcessClinical trial designClinical trial managementClinical trialsContract negotiationCommunication SkillsCTMSData cleaningElectronic Data Capture (EDC) EnglishEthics submission and approval processGCPGood Clinical Practice (GCP)HematologyICH-GCPInformed Consent ProcessMedical oncology Microsoft OfficeoncologyPatient Reported Outcome Measures (PROMs)Patient Screening and RecruitmentPharmaceutical IndustryPhase IIPhase IIIProject ManagementQuality of Life (QoL) outcomesRandomization and blindingRegulatory submissionsSupervising CRAsSerious Adverse Event (SAE)Informed Consent Documents
LinkedIn Assessment :
Clinical trialsoncologyClinical monitoringCTMSGCPICH-GCPPharmaceutical IndustryRegulatory submissionsTherapeutic AreasClinical operationsSOPPatient recruitmentBudget ForecastsFeasibilitiesProject OversightFinancial OversightClinical DevelopmentHematologyLymphomaLeukemiaMultiple MyelomaMicrosoft ExcelMicrosoft WordProject ManagementR&DClinical researchMicrosoft OfficeStudy Coordination

Skills and Expertise

Self Assessment :
Design case record forms Create SOPs Monitor a clinical studyApprove monitoring reportsApprove consent documentsAssess site feasibilityAssist study siteCollaborate with medical teamCollaborate with principal investigatorCollaborate with project teamAttend investigator meetingCommunicate with investigatorConfirm protocol complianceCoordinate with the ethics commiteeEthics committee applicationEthics committee submissionsInteract with ethics committeeEnsure good clinical practice (GCP)Identify investigatorsIndentify sitesInformed consent processConduct site initiationInteract with CROsManage study budgetOral presentationorgaoralSupervise clinical monitorsOrganise meetingsPatient recruitmentPre-study procedures Negotiate budget Regulatory submissionsReview monitoring reportsConduct monitor visitsSelect investigators

Education

  • Assistant Nurse in Medicine from S:t Göran in 1986
  • in Medical Administrative/Executive Assistant and Medical Secretary from S:t Görans school in 1980
  • in Regular/General High School/Secondary Diploma Program from Gångsätra school in 1978

Languages

BrightOwl Assessment:
Self Assessment:
Swedish
Native
English
Professional Proficiency
German
Elementary Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Positions I am interested in:
    associate Clinical Project Manager Clinical Project Leader Clinical Research Manager Clinical Trial Manager Project Leader Senior Clinical Research Associate (CRA) Project Manager Senior Clinical Research Associate (CRA) Senior Clinical Research Associate (CRA) Clinical Project Manager (CPM) CRM
  • Locations I am interested in:
    Stockholm, Sweden
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Stockholm, Sweden

Others

Driving License
  • Yes

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