Dr. Mihaela Cernescu

Leading Activation and Initiation of Clinical Studies Prepare, review, and coordinate local regulatory submissions (MoH, Ethics Committees, and country-specific requirements) in line with global strategy Work closely with cross-functional teams to keep study start-up activities and timelines aligned Act as the main country-level contact for regulatory submissions and stay in close contact with investigators and study sites

Managed the local documentation system and local implementation of the European documentation. - Coordinated regular revision of the SOPs and Quality Manual  - Monitored, estabilished the actions and prepared the close-outs for Change Control and CAPA system.  - Generated KPIs for documentation, training and Service Complaint Systems.

- managed study site activation and preparation of new or amended submission packages to Central / Local Ethics Committees as appropriate - Performed administrative tasks required during study start up activities

Project Management Regulatory Affairs Clinical studies Quality management

Laboratory for Protein Analysis and Screening • Responsible for performing different biophysical assays and to write the reports for clients in Germany or abroad

Intensive german course, B2kevel

Established the LILBID-MS technique as a novel technique to study Aβ oligomerization and to characterize the earliest nucleation events thought to be crucial in Alzheimer's disease (AD); Investigated protein–protein interaction, protein complexes and protein stoichiometry within protein complexes by means of Laser-Induced Liquid Bead Ion Desorption Mass Spectrometry (LILBID-MS). August 2012- February 2014- Parental leave

Physical Chemistry practical courses for Pharmaceutical students • Conducted and guided the pharmaceutical students during the physical chemistry practical courses; • Maintained the experimental setups, reviewed and corrected the students’ laboratory protocols; • Planned and supervised the projects of the graduate students for the Traineeship Thesis.

Doctor Thesis: "Characterization of protein assembly formation by Laser Induced Liquid Bead Ion Desorption Mass Spectrometry"

Master Thesis performed at Max-Planck Institute for Biophysics, Frankfurt/Main, Germany