Clinical Project Manager

12/2020 – 3/2021

selection of and negotiation with vendors; primary point of contact for sponsor; project management of a phase IV pan-European trial in 9 countries; preparation of trial related documents (Monitoring Plan, TMF Management Plan); collaboration with Quality Assurance department (SOP Review); collaboration with proposal management department and participation in bid defense meetings

Gute Klinische Praxis

6/2020 – 11/2021

main responsible for development program of a cannabis-based drug in Europe from pre-clinic, over Phase I till Phase III
main responsible for clinical trials for food supplements and medicinal products
Personnel responsibility for 10 people
Set Up of quality management system
Selection of vendors for clinical trials (data management, monitoring, pharmacovigilance, labs, etc.)

Gute Klinische Praxis

6/2014 – offen

CEO
GCP Trainer

Gute Klinische Praxis