Pavlos Koulouritis

Sr CTA, embedded to BAYER Hellas

• Performing submissions to NEC and coordinating submissions to EOF, under EU_CTD.
  Fully responsible for preparation and development of NEC dossier, also reviewer of EOF dossier
• Develops and overviews execution of Clinical Trial Agreements (initial and amendments)
• Primary Point of Contact with NEC, Management Bodies, Hospitals and vendors
• Payment support
• Mentoring new colleagues

Supporting >10 interventional clinical studies

CTA/Study Start-up Specialist, embedded to BAYER Hellas
0.5 FTE SSU (member of global team)

• Performing submissions to NEC and coordinating submissions to EOF, under EU_CTD. Fully responsible for preparation and development of NEC dossier, also reviewer of EOF dossier.
• Develops and overviews execution of Clinical Trial Agreements (initial and amendments)
• Primary Point of Contact with NEC, Management Bodies, Hospitals and vendors
• Performing QC in eTMF
• Providing payment support

Supporting >10 interventional clinical studies

• Clinical Trial Agreements for ELKEA/ ELKE/ Public and Private Hospital Sites/ Vendors - Development and Submissions
• Contract Amendments to ELKEA/ ELKE/ Public and Private Hospital Sites/ Vendors
• Compiling submission packages
  Central Ethics Committee (EED) submissions
  National Competent Authority (EOF) submissions
  Local Ethics Committees submissions
  

Providing general support to Clinical Operations