BrightOwl Loader Loading

Summary

I have been working with clinical trials and regulatory affairs from the year 2006. I have worked as a Lead CRA, Senior CRA, CRA and Regulatory Affairs Officer. Many different indications are familiar to me. My current job is to work as a Study Authorization Associate II in ICON Clinical Research. My responsibilities are: take care of start up phase of clinical trials, writing and collecting EC and CA submission packages, collecting CDP documents, negotiating study budgets and contracts. I have also taken care of ICF documents for patients and quality of those for all around the World. I have experience from clinical trials from very beginning of them to the end of studies. I have been taken care by myself of everything between that. All phases I-IV are familiar to me. In addition to above mentioned experience, I have done also feasibilities, a lot of monitoring, IP import processes, study close-outs in Finland and Baltic countries. Regulatory affairs procedures are also very familiar to me. I have been writing documents to MA applications, variations and renewals of them. I have also written or re-written drug information sheets. Regulatory affairs work contains countries in all continents. Working in international environment is my daily routine and English is my work language. I am also used to travel in my work, be flexible and take care of timetables and budgets. I have been also a responsible person of taking care of budgets and project management. My background contains also experience from educating and training colleagues or health care professionals in companies, hospitals, laboratories and in private practices. I have studied pharmacy, biology, chemistry, biochemistry, statistics and pedagogics in the universities of Helsinki and Oulu. Pedagogical background helps when training or educating people, what ever age they are. I am Licentiate of Pharmacy, Master of Sciences (Biol.) and professional Biology and Chemistry teacher.

Experiences

Current Experience

  • Project Manager/Senior CRA
    Since September 2015

  • Study Authorization Associate II
    Since September 2011
    My job contains study start up phase of different kind of clinical trials. I have done a lot of budget and contract negotiations. I have experience also from feasibilities, EC and RA applications, drug release, CDP packages, label reviews and arranging teleconferences. At the moment I have been writing or reviewing patient documents for all around the World.

Past Experience

  • Lead CRA/Senior Clinical Research Associate/ Regulatory Affairs Officer
    February 2008 --- August 2011
    I took care of clinical trials from the beginning of the trials to the end of them. I have done phases II-IV, and I take care of contracts and budgets too. I did much internal and external trainings and education sessions. I also educated junior CRAs. I have also experience as a Lead CRA for a group of CRAs (Finland, Estonia). My experience contained cardiology, intestinal, psychiatry and neurology studies. Some cancer studies too. I have done EC and CA applications and submission packages, involved with contracts and budgets, done monitoring and site management, site closing etc. I also worked with regulatory affairs doing and writing MA applications, variations, renewals and other maintenance work with marketing drugs.

  • Clinical Research Associate (CRA)
    September 2006 --- January 2008
    I got a lot of experience of monitoring clinical trials, I also started studies and closed them. I took care of everything by myself from the beginning of the studies to end of them, also budgets and contracts. A lot of traveling.

  • Biology and Chemistry Teacher
    August 2004 --- July 2005
    Teaching biology and chemistry for teenagers between 13-16 years. Educating, teaching, parenting children and teenagers. Arranging many visits to local biotechnology companies, visits to forests and strands, doing a lot of chemical tests and procedures with pupils.

  • researcher
    January 2000 --- January 2003
    I was doing research work with microbiology and plant extracts/ essential oils, doing chemical GC/MS analysis, teaching students, doing gene analysis, supervising student's thesis works in Department of Pharmacy.

Knowledge

LinkedIn Assessment :
Clinical trialsoncologyClinical DevelopmentClinical monitoringRegulatory affairsPharmaceutical IndustryCROChemistryPharmaceuticsNeurologyClinical researchEducationTeam LeadershipStatisticsCell biologyProject PlanningICH-GCPCardiologyGCPCTMSRegulatory submissionsEC submissionsRA submisisonmaking contractsMaking variations for MAs of drugsPlanningProblem SolvingOrganizingAdult EducationElementary EducationMedical EducationTeachingTeaching AdultsUniversity TeachingContract negotiationContract ManagementStudy MonitoringStudy CoordinationStudy ReportsPedagogy

Education

  • Professional biology and chemistry teacher in Pedagogigs from University of Helsinki in 2004
  • Licentiate of Pharmacy in Pharmacy from University of Helsinki in 2003
  • Master of Sciences in Biology, Chemistry, Biochemistry, Genetics, Zoology, Plant Physiology, Statistics, from University of Oulu in 1999

Area / Region

Finland

Others

Driving License
  • No