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Summary

New innovations and progress in the field of clinical trials are close to my heart. I have several years of experience in international, multicenter, phase I-IV clinical studies, and working in cross cultural and virtual teams. I've been involved in clinical study process all the way from study start-up to site close-out and within multiple indication areas. I'm interested in improving people's quality of life. My education, Bachelor of health sciences and engineer of biotechnology, gives great basis for working in clinical studies. I am an efficient organizer, good at making things happen within timetable, systematic, practical and service orientated. I am a great team worker with a positive attitude. Prior to my biotechnology studies, I worked as a nurse at different hospital wards in Finland and in Sweden. Working as a nurse has given me readiness to confront different kind of people and the clinical terminology is familiar to me. Key Words: Clinical Research, Clinical Trials, Feasibility, Site ID, Project Administration, GCP, CRO, CTA Skills: Efficient Organizer, Team Worker Personal interests: Dancing and music.

Experiences

Current Experience

  • Project Associate
    Since January 2015

Past Experience

  • Site ID Services Specialist
    July 2014 --- January 2015
    -To manage Capability, Feasibility and Site ID opportunities for Finland, Sweden, Norway and Denmark, identify potential new sites - Distribute, track, negotiate and review the Confidential Disclosure Agreements - Review Site Identification Forms for site capability and suitability of investigators - Collect, review and reconcile country Feasibility / Site Identification data - Maintain and update information repositories and databases.

  • Feasibility/ Site ID Specialist
    April 2012 --- June 2014
    - Taking responsibility of local capability exercises and larger feasibility projects -Perform, manage and coordinate activities associated with identification of sites for projects -Maintain and update departmental information repositories and databases - Assist in collecting and reviewing documents for investigational product release.

  • Clinical Trial Assistant (CTA)
    June 2011 --- April 2012
    - Maintain unit and clinical trial files (eTMF) - Collection, tracking, verification and appropriate dissemination/distribution of essential documents - Organisation of all translations in local language, when required, of all study related documents - Release investigational product to investigators - Coordinate return and destruction of unused clinical supply - Requisition of study-related payments.

  • QA Engineer
    May 2007 --- May 2011
    - Responsible of quality management system - Assist in GCP audits - Source Data Verification - GLP audits in Europe - GCP and GLP training

  • Engineer of Biotechnology
    September 2008 --- March 2009
    - Writing and developing test protocols for microbiological tests - General laboratory work.

  • Nurse
    September 2002 --- December 2004
    Nurse, in different wards. - Responsible of pharmaceuticals at psychiatric ward.

  • Nurse
    May 2002 --- September 2002
    Nurse in neurological rehabilitation ward.

Knowledge

LinkedIn Assessment :
Clinical trialsGCPSOPCROClinical researchBiotechnologyICH-GCPCTMSRegulatory submissionsDiabetesPharmaceutical IndustryRegulatory affairsClinical DevelopmentVaccinesValidationQuality AssuranceGMPMedical Devices

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF) Create SOPs Guide students Interact with nurses Interact with physicians Interpret data Monitor a clinical study Report data Search literature on clinical trials Use content management systemsAct as the main line of communication between the sponsor and the investigatorAdjust processes and methodsAdminister logisticsAdminister supply requestAdminister, maintain and co-ordinate the logistical aspects of clinical trialsAdministrative supportAdverse event reportingArchive documentationArchive study documentsArchive trial documentation and correspondence.Aseptic techniquesAssess site feasibilityAssess subject safetyAssist study siteAssist with experimentsAssist with proceduresAssist with routine testsAssist with site trainingBuild trial master file (TMF)Coach and provide guidance to clinical staff.Collaborate with medical teamCollaborate with project teamCollaborate with principal investigatorCommunicate with sponsorCommunication

Education

  • Bachelor's Degree in Engineer of Biotechnology from Turku University of Applied Sciences in 2008
  • Bachelor's Degree in Registered Nursing/Registered Nurse from Turku University of Applied Sciences in 2001

Training and Certification

  • CRA EAPA Bridge Program in 2016 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    Finnish
    Native
    English
    Full Proficiency
    German
    Elementary Proficiency
    Swedish
    Elementary Proficiency
    Norwegian
    Elementary Proficiency
    French
    Elementary Proficiency

Area / Region

Finland

Others

Driving License
  • No