Birgit Höhne

Experience

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  Centre for Addiction and Mental Health

  Mar 2007 - Jul 2007

  Research Internship

  Public Health and Regulatory Policy Section

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  IFT Institut für Therapieforschung

  Jul 2009 - Apr 2010

  Project Manager

  Managing all project-related activities of a study about pathological gambling, main point of contact for internal/external project partners, development of study documents, statistical analysis

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  Helmholtz Zentrum München - German Research Center for Environmental Health

  May 2010 - Feb 2014

  Project Manager

  Coordinating, steering, and monitoring of project avtivities (KORA-study), main point of contact for internal scientists/external partners and vendors, submissions to ECs/RAs; development of study documents and trainings, organization of meetings and project conferences, progamming SAS

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  Division of Infectious Diseases & Tropical Medicine; Ludwig-Maximilians-Universität München

  Apr 2014 - Dec 2015

  Project Manager

  Managing of international epidmiological projects• Act as first contact for all operational issues• Prepare study-specific documents• EC submission• Montitoring of study progress • On-site Monitoring

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  Kantar Health

  Jan 2016 - Mar 2018

  Project Manager

  Project Lead for Non-Interventional Studies (NIS) and PASS studies. Indication: cardiovascular disease, dermatology, ophthalmology• Coordination, implementation and monitoring of non-interventional studies (NIS) and PASS studies.• Central contact for clients, study team, study centres and suppliers• Responsible for establishing study-specific processes according to protocol, GCP guidelines and regulatory requirements• Responsible for the management of the study budget including invoicing to the client • Responsible for adherence to milestones and timelines• Development and review of study-related documents• Preparation and submission of studies to ECs/RAs• Training of study staff• Processing of payments (physicians, suppliers)• Coordination and supervision of monitoring activities by CRAs• Preparation and maintenance of ISF/TMF Show less

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  Cerner Enviza (formerly Kantar Health)

  Jul 2018 - Jun 2022

  Project Manager

  Project Lead for Non-Interventional Studies (NIS) and PASS studies. Indication: cardiovascular disease, dermatology, ophthalmology• Coordination, implementation and monitoring of non-interventional studies (NIS) and PASS studies.• Central contact for clients, study team, study centres and suppliers• Responsible for establishing study-specific processes according to protocol, GCP guidelines and regulatory requirements• Responsible for the management of the study budget including invoicing to the client • Responsible for adherence to milestones and timelines• Development and review of study-related documents• Preparation and submission of studies to ECs/RAs• Training of study staff• Processing of payments (physicians, suppliers)• Coordination and supervision of monitoring activities by CRAs• Preparation and maintenance of ISF/TMF Show less

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  M3i Industry-in-Clinic Platform

  Jul 2022 - Sept 2022

  Consultant Project Management

  • Consulting activity regarding establishment of a clinical study centre for the performance of PMCF-studies

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  Ipsos

  Apr 2023 - Nov 2024

  Manager (NIS Lead Germany)

  Set-up and management of the Non-Interventional Study (NIS) Services at Ipsos including: • Developing and adapting a strategy for the NIS area.• Creating the infrastructural requirements for the implementation of NIS.• Preparation of marketing documents• Identification and management of internal and external suppliers• Consultation of clients• Management and monitoring of NIS• Preparation of project calculations and project controlling

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  Alcedis - a HUMA company

  Nov 2024 - now

  Senior Project Manager