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Summary

seasoned sat lead and senior study start up Associate (sr ssua) with excellent interpersonal, organizational and Leadership skills. extensive experience with Clinical operations and Clinical Trial start up activities. solid knowledge of ich-gcp, ethical and regulatory requirements in submissions of Clinical trials. skilled in providing effective clinical Presentations to internal and external audiences. establishing and developing professional relationships with customers, internal team and Health professionals. have a phd in experimental oncology. specialties oncology, Clinical trials, Clinical research, Pharmaceuticals, ich-gcp, regulatory submission, Ethics committee submission, data protection, monitoring, Leadership, presentation, study startup, Regulatory Compliance review, audit experience, quality metrics.

Experiences

Current Experience

  • Sr SSUA


    Since March 2011
    working as senior study start up Associate in site activation team (sat) Working as Senior Study Start Up Associate in Site Activation Team (SAT)

Past Experience

  • SAT Lead

    August 2014 --- April 2015
    coordinating Clinical trials submissions to ca and ecs within europe. serve as the primary contact with sponsor, pm other functional leads and third parties who have an impact on study start up.

  • Sr SSUA

    April 2014 --- August 2014
    a 4 months secondment as a senior ssu Associate at uk ssu department. responsible for the independent preparation, review and approval of country related submission packages in accordance with ich, gcp and all applicable regulations, laws and other guidelines and ethical standards.

  • Senior SAA

    July 2010 --- February 2011
    preparation of Applications to competent authorities and regional ethical review board mainly in sweden

  • SAA II

    November 2008 --- June 2010
    preparation of Applications to competent authorities and regional ethical review board mainly in sweden

  • Consultant

    February 2004 --- November 2008
    preparation of a manual on how to perform academic phase-i studies in oncology. eortc liaison office in stockholm, preparations of Applications to erb and ca for eortc studies in nordic countries.other contract jobs at karolinska institute and in Pharmaceutical Industry.

  • Senior Clinical Research Associate (CRA)

    December 1999 --- January 2004
    conducting prestudy visits in the nordic countries, austria and germany. monitoring Investigator sites in the nordic countries. project coordination, feasibility evaluation and participation in client meetings.

  • Clinical Research Associate (CRA)

    April 1996 --- November 1999
    managed phase 1-3 protocols in lung Cancer, ovarian Cancer, bladder Cancer, breast Cancer, head and neck Cancer, endometrial Cancer, Osteoporosis and urine incontinence for investigational drugs at sites across sweden

  • Clinical Research Associate (CRA)

    December 1993 --- March 1996
    authorised protocols in collaboration with investigators and preparation of crfs and data base for data. preparation of Applications to ca and erb. responsible for all serious adverse event reporting in non-registrational studies.

  • Research Student

    August 1988 --- November 1993
    working with Research resulting in several articles of which 5 is included in the thesis ”experimental studies on estramustine and radiation in the Treatment of prostate Cancer

Personality

Self Assessment :
Analytical thinkingCollaborationCommunicativeCompetitivenessDependabilityFlexibilityProblem solvingSelf-confidence

Knowledge

Self Assessment :
Cell biologyAllergy and immunologyAntibodiesAuditingBiochemistryBiologyBiomarkersCancer ResearchClinical monitoringClinical researchClinical trial audits and inspectionsCROEnglishEthics submission and approval processGood Clinical Practice (GCP)Microsoft OfficePresentation SkillsProblem SolvingRegulatory submissionsStart-ups
LinkedIn Assessment :
CROCTMSoncologyICH-GCPClinical trialsPharmaceutical IndustryGCPProtocolClinical researchCancerRegulatory submissionsClinical Data ManagementClinical monitoringClinical Development

Skills and Expertise

Self Assessment :
Calculate trial timelinesCollaborate with principal investigatorCollaborate with project teamCommunicate with investigatorDesign information leafletEnsure good clinical practice (GCP)Ethics committee submissionsManage clinical trial files/documentsManage multiple projectsRegulatory submissionsRespond to audit findingsSolve problemsWork collaboratively with the other members of the clinical research team

Education

  • PhD in Experimental Oncology from Uppsala University in 1992
  • PhD in Experimental oncology from Uppsala University in 1992
  • PhD in Experimental oncology from Uppsala University in 1992
  • B.Sc. in Human Biology from Uppsala University in 1988

Languages

BrightOwl Assessment:
Self Assessment:
Swedish
Native
English
Full Proficiency

Work Preferences

  • Notice Period:
    9 weeks
  • Positions I am interested in:
    Clinical Operations Manager Regulatory Affairs Associate Regulatory and Start-Up Specialist
  • Locations I am interested in:
    Stockholm, Sweden
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    80-100% FTE
    BrightOwl employee :    80-100% FTE
  • International:
    Yes

Area / Region

Stockholm, Sweden

Others

Driving License
  • No

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