Experience

• 

  Aca, angewandte chemie adlershof

  Sept 1998 - Sept 1999

  Laboratory assistant

  metal organic catalysts for synthesis and polymerization

• 

  Freie universität berlin

  Oct 1999 - Aug 2001

  Scientific collaborator

  - supervision of students- fluorine chemistry- NMR, MS, HPLC, GC

• 

  Ams advanced medical services

  Sept 2001 - Jan 2004

  Cra

  - Regulatory / EC applications (Germany, Finland)- PSV, Monitoring, Close out (Germany, Finland, Denmark)- Supervision of new CRAs- Translation of study documents- Grass pollen allergy- Atopic Dermatitis

• 

  Smerud medical research

  Feb 2004 - Feb 2016

  Senior cra

  - Regulatory / EC applications (Finland, Sweden, Germany)- Feasibility, PSV, Monitoring, Close out (Finland, Sweden, Germany)- Supervision of new CRAs- Translation of study documents- Internal Audits- Atopic Dermatitis, Hand Dermatitis- Hypertension- Vaccine studies (HPV, Pneumococcal infection, Influenza, Meningococcal, Herpes Zoster)- Diverticulitis, Celiac Disease- Chondrocyte Implantation, Hip implant device- Post-Amputation Stump Pain- Breast Cancer, Lung Cancer, Leukemia- Rheumatology, Ankylosing Spondylitis, Joint Arthritis Show less

• 

  Tilt biotherapeutics

  Mar 2016 - Oct 2016

  Head of clinical operations

  Oversee clinical activitiesManage CRO activities (hiring CRO, auditing CRO SOPs etc.)Oversee study start-up und monitoring Review of monitoring reportsDistribution on Clinical Trial ProtocolsOncology / Melanoma

• 

  Abbvie

  Oct 2016 - Aug 2019

  - Clinical Study Start-Up- Site Feasibility- Monitoring- Financial Contracts- CA/EC submissions- Alzheimer´s Disease- Chronic Lymphocytic Leukemia (CLL)- Acute Myeloid Leukemia (AML)

  • Senior Clinical Research Associate

    May 2017 - Aug 2019

  • Global Study Representative - NeuroScience/Oncology

    Apr 2017 - Aug 2019

  • Senior Site Clinical Research Associate

    Oct 2016 - Aug 2019
• 

  Oriola corporation

  Sept 2019 - Sept 2020

  Senior clinical research associate

  Responsible for sites in Sweden and Denmark.Providing SOPs for monitoring work.

• 

  Clinical research services turku crst

  Oct 2020 - Nov 2021

  Project manager

  Overseeing development of studies (FiH, Ph I-III), including study protocols, laboratory manuals, working manuals, monitoring manuals.Feasibility of and contracting with vendors.EC and CA submissions.Maintenance of quality standards within the company.

• 

  Oriola corporation

  Dec 2021 - now

  Project manager and gcp auditor

  Overseeing monitoring in the Nordic and Baltic countries.Site Quality VisitsTraining of CRAsSite Feasibility and Site SelectionContracting with clinical sitesEC submissionsWriting and review of SOPs