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Summary

I am goal oriented, time line conscious, prioritising, focused and resilient. I have a clinical trial and science background (research in neuroscience + immunology). I want to work in a challenging and rewarding work environment to create value for the company I work for and myself.

Experiences

Current Experience

  • Senior Clinical Trial Specialist
    Since May 2015
    I organize and prepare clinical trial submissions to ethics committees as defined by effective SOPs and according to ICH-GCP, local regulatory requirements and study specific guidelines. I am tracking of processes as well as follow-up on clinical trial applications to a large number of ethics committees in Germany, Austria and Switzerland. I act as team country coordinator. I am responsible for submissions of clinical trials for infectious-, cardio vascular- and neurological diseases (Phase II - IV). I train new colleagues in Clinical Trial Specialist tasks.

Past Experience

  • Clinical Trial Specialist II
    May 2013 --- April 2015
    I organize and prepare clinical trial submissions to ethics committees as defined by effective SOPs and according to ICH-GCP, local regulatory requirements and study specific guidelines. I am tracking of processes as well as follow-up on clinical trial applications to a large number of ethics committees in Germany, Austria and Switzerland. I act as team country coordinator. I am responsible for submissions of clinical trials for infectious-, cardio vascular- and neurological diseases (Phase II - IV).

  • Clinical Trial Specialist (CTS)
    February 2011 --- April 2013
    I organize and prepare clinical trial submissions to ethics committees as defined by effective SOPs and according to ICH-GCP, local regulatory requirements and study specific guidelines. I am tracking of processes as well as follow-up on clinical trial applications to a large number of ethics committees in Germany, Austria and Switzerland. I provide support and maintain records in the clinical trial central file/trial master file (hard copies/electronic data). I develop country specific patient Information and informed consent forms in accordance with ICH/GCP and local regulatory requirements. I act as team country coordinator. I frequently update the report on study progression during its START phase in collaboration with Project Lead/Clinical Operations Lead. I communicate the status to PL/COL. I identify and communicate priorities to team members. I am responsible for submissions of clinical trials for infectious-, cardio vascular- and neurological diseases (Phase II - IV).

  • Senior Scientist
    December 2004 --- December 2010
    I investigated neurological disorders such as Alzheimer, Huntington and Parkinson disease for common and unique pathology. I strived to identify biomarkers to predict disease progression in order to monitor clinical trials effectively. I was responsible for Ph.D. and Master students and acquisition of research funding. I was managing my own projects and personnel. I initiated and maintained national and international cooperations with fellow researchers. I published more than 30 scientific papers in peer reviewed journals.

  • Postdoctoral Researcher (PostDoc)
    January 2003 --- November 2004
    Research in Huntington disease and related neurodegenerative disorders such as Alzheimer or Parkinson disease. I was responsible for Ph.D. and Master students and acquisition of research funding.

  • Graduate student
    May 1999 --- December 2002
    Research into protein alterations during Huntington disease progression; search for possible biomarkers

  • Research associate
    April 1997 --- March 1999
    I conducted immunological research to identify synthetic ligands for MHC I molecules in order to increase their half live and thereby facilitate the lasting treatment of e.g. autoimmune disorders that require a modulation of the immune system.

Personality

Self Assessment :
AdaptabilityAssertivenessCommunicativeCritical thinkingEfficiencyFlexibilityInnovative thinkingSelf-confidenceStrategic thinkingSelf-disciplineResponsibility

Knowledge

LinkedIn Assessment :
Clinical trialsImmunologyClinical researchRegulatory affairsNeuroscienceProtein chemistryBiotechnologyLifesciencesLife SciencesRegulatory submissionsmolecular biologyBiochemistryCell CultureDrug DevelopmentCell biologyGeneticsMicrobiologyCommunicationTeamworkResearchscienceMedical EthicsLeadershipBioinformaticsStatisticsHealthMolecular geneticsClinicalTeam ManagementProject ManagementProject PlanningOversight

Skills and Expertise

Self Assessment :
Analytical skills Analyze data Control data Develop protocols Interact with physicians Interpret data Search literature on clinical trials Write papersAdjust methodsAdjust processes Advise on strategyAlzheimerCell cultureCollaborate with medical teamCommunicate effectively on different company levelsR&DResearch at universitiesRetrieve study documentsReview exclusion criteriaReview inclusion criteriaReview queriesSet up a clinical studyShipment of biological specimenTeach university studentsUse western blotting techniqueWork cross-functionallyWrite final reports

Education

  • Clinical Trial Management in Clinical Trials from PAREXEL Academy in 2011
  • Ph.D. (Dr. rer. nat.) in Cell Biology from Humboldt-Universität zu Berlin in 2003
  • Dipl. Ing. in Biotechnology from Beuth University of Applied Sciences Berlin (formerly Technische Fachhochschule Berlin) in 1996

Languages

BrightOwl Assessment:
Self Assessment:
German
Native
English
Full Proficiency
French
Elementary Proficiency

Work Preferences

  • Notice Period:
    9 weeks
  • Positions I am interested in:
    Manager Regulatory Affairs Consultant Senior Scientist
  • Locations I am interested in:
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    FTE 100% FTE
  • International:
    No

Publications

    Expert has 2 publications (Will be avalible with full profile)

Area / Region

Germany

Others

Driving License
  • Yes