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Summary

claes jagensjö is a Consultant providing services in Clinical research (Phase I-iv) in the nordics countries (sweden, norway, denmark and finland), primarily in clinical project leading.

with more than 15 years of experience from Pharmaceutical companies and CRO:s (contract research organisation) in managing national and international Phase I to Phase IV Clinical trials, all the way from the feasibility and study start to the final clinical study report; including study outline, Planning, coordination, monitoring, management, performance, termination and reporting of the trials.

claes jagensjö has experience in clinical project leading in Clinical trials having an overall administrative responsibility to supervise, co-ordinate and lead study specific activities and to implement and conduct a clinical study in accordance with the company SOP´s, ich-gcp requirements and local regulations.

Experiences

Current Experience

  • Consultant and Owner


    Since January 2010
    Consulting services within Clinical trials. Consulting Services within clinical trials.

Past Experience

  • Regional Medical Liaison

    June 2005 --- December 2009
    - responsible for Quality Assurance projects and the company’s contact person for academic study groups and isss in the oncology / haematology field. - Communication of complex scientific information and Research concepts to Healthcare decision makers. - conducting study feasibilities

  • Associate Development Operational Manager

    June 2005 --- January 2007
    - responsible for the Clinical trials in the oncology / haematology field in the nordic countries, including having an overall responsibility to supervise, co-ordinate and lead study activities. - managing a team of 3 cras and 1 CRO liaison.

  • Busniess Developer

    April 2003 --- June 2005
    - responsible for Marketing in the nordic countries of the cros activities and customer relationship. - customer meetings, offer and contract writing. - Clinical trial management of Clinical trials including crf design, Data Management duties and coordination and management of study team, setting up study Documentation, also including SOP:s, and budget responsibility for Clinical trials.

  • Clinical Research Manager

    May 2001 --- April 2003
    - Clinical trial management of clinical trial including Data Management duties and assisting in coordination of study team, setting up study Documentation, also including SOP:s, and budget responsibility for Clinical trials. - responsibility for study drug handling in the nordic countries for a study with more than 4000 patients. - responsibility for a genetic sub-study.

  • Senior Clinical Research Associate (CRA)

    April 2000 --- May 2001
    - conducting of multicentre Clinical research studies in the nordic countries as Investigator recruitment; evaluates, initiates, monitors and closes out sites. - lead CRA in an european multinational study and responsible for 2 countries (poland and france).

  • Clinical Research Associate (CRA)

    April 1998 --- March 2000
    - conducting of multicentre Clinical research studies in the nordic countries as Investigator recruitment; evaluates, initiates, monitors and closes out sites.

  • Clinical Research Associate (CRA)

    January 1996 --- April 1998
    - conducting of multicentre Clinical research studies in the sweden as Investigator recruitment; evaluates, initiates, monitors and closes out sites.

  • Clinical Research Associate (CRA)

    January 1995 --- January 1995

  • Medical Sales Representative Gothenburg, Sweden

    February 1992 --- January 1994

Personality

Self Assessment :
CollaborationCommunicativeCoordinationEfficiencyFlexibilityInterest in knowledgeOrientationProactivityProblem solvingResult OrientedService orientedTrust

Knowledge

Self Assessment :
Good Clinical Practice (GCP)A rising single dose tolerance studyActions and modes of action of drugs in the human speciesAllergy and immunologyAntibodiesBiomarkersBudget NegotiationCardiovascular diseasesClinical monitoringClinical trial audits and inspectionsClinical trial budgetingClinical trial managementClinical Trial Management System (CTMS)CRODiabetesHematologyMedical DevicesMicrosoft OfficeoncologyOutsourcingPhases of clinical development (phase I to IV)Project ManagementQuality Assurance (QA)Regulatory submissionsTrainingVaccines
LinkedIn Assessment :
Clinical trialsClinical researchoncologyClinical trial managementCROLifesciencesMedical writingCTMSPharmaceutical IndustryDrug DevelopmentRegulatory affairsGCPClinical pharmacologyPharmacovigilancePharmacokineticsICH-GCPSOP

Skills and Expertise

Self Assessment :
Create SOPs Develop clinical trial protocols Interact with nurses Interact with physicians Monitor a clinical study Search literature on clinical trialsAct as the main line of communication between the sponsor and the investigatorAdjust processes and methodsApprove monitoring reportsApprove patient informationApprove drug supply Approve Label Master SheetAssess site feasibilityAssist study siteAssure medical qualityAttend at steering committee meetingsAttend steering committeeCalculate timelines for conducting and completing the trialCoach

Education

  • MSc Pharm in from Uppsala universitet in 1992

Languages

BrightOwl Assessment:
Self Assessment:
English
Professional Proficiency
Swedish
Native
Danish
Professional Proficiency
Finnish
Elementary Proficiency

Work Preferences

  • Notice Period:
    13 weeks
  • Positions I am interested in:
    associate Clinical Project Manager Clinical Project Leader Clinical Operations Manager Clinical Project Manager (CPM) Clinical Research Associate (CRA) Clinical Research Consultant Clinical Research Manager Clinical Trial Manager (CTM) Compliance Manager CRM QA Consultant QC/QA Manager Regulatory and Start-Up Specialist Senior Clinical Research Associate (CRA) Study Start-up Specialist Translator
  • Locations I am interested in:
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    BrightOwl freelancer :    40 Hours per week
  • International:
    Yes

Area / Region

Stockholm, Sweden

Others

Driving License
  • Yes

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