Experience

Qualitis SA - now part of Optimapharm Group

• Greece
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Contract Management Specialist for Greece and Adria Countries at Abbvie

  • Dec 2020 - Present



Novo Nordisk

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• • Sep 2018 - May 2020

• • Jan 2014 - Sep 2018

  Key responsibilities:1) Project manager for the trial management activities in the country from site selection to post-clinical trial activities 2) Coordinating tasks and communication with the Regional Trial Mgr (RTM) or International Trial Mgr (ITM) at HQ in order to facilitate progress and global coordination of the clinical trial program3) Responsible for escalating issues to the local line manager, RTM or ITM and seeing to consistency of the trial sites 4) Proactively drive the clinical trial activities in the country forward, and deliver results that have a direct impact on the successful completion of the clinical program5) Responsible for the country budgets of the clinical trialsMain job tasks:Project management• Overall trial organisation and coordination within GR• Represent clinical operations from GR in the International Study Group (ISG) • Ensure compliance with the application and communication of all Novo Nordisk policies, essentials and procedures• Accountable for all project timelines and deliverables within GRTrial activities:• Accountable for the country budget of haemophilia trials • Provide consolidated country input for review of key documents (e.g. protocol)• Responsible of IMPACT at country level (Superuser) and trainer of CRAs on updates • Prepare the country recruitment and mitigation plan • Monitor recruitment and retention of trial subjects and act accordingly to the agreed country plan • Provide trial status update and other reports or feedback as required to the RTM or ITM• Ensure data cleaning milestones and DBL deliverables according to the Data Flow Plan• Ensure compliance with GCP, ICH and local regulations• Initiate and drive contracts with sites as per local practice• Responsible for start up activities (submission to HA, NEC, local ECs - contracts)• Responsible both in haemofilia and diabetes trials• User of ClinPhone, e-diaries (PHT), InForm 4.6 and 6.0, Infosario (Quintiles) etc. Show less



Roche Hellas

• CRA

  • Apr 2007 - Jan 2014

  Primarily Oncology, but also Hepatitis and Rheumatoid Arthritis in Phase II, IIIa, IIIb Interventional studies as well as in phase IV non-Interventional studies. Primarily Oncology, but also Hepatitis and Rheumatoid Arthritis in Phase II, IIIa, IIIb Interventional studies as well as in phase IV non-Interventional studies.



Moody Hellas

• Quality Consultant

  • Nov 2003 - Apr 2007

  1. Planning, development optimization and commissioning of Quality Systems based on ISO standards (ISO 9001:2000, ISO 22000 and ISO 17025) in companies of Greece and Cyprus 2. Maintenance of Quality Systems and Audit preparation 3. Systems’ upgrade to ISO 9001:2000 4. Training sessions based on quality systems 5. Training sessions for Internal Auditing 6. Quality Assurance Manager in in companies of Greece and Cyprus 7. Internal Auditor for Quality Systems 8. Communication with customers and update of Quality Systems and Standards Show less



HENRY DUNANT HOSPITAL

• Dept of System Administration

• Quality Assurance Consultant (Athena Consultancy)

  • May 2003 - Nov 2003

  1. Internal Audits based on the ISO– 9001:2000 and ΕLΟΤ 1416 standards 2. Maintenance of quality systems of ISO 9001 and HACCP and preparation of external audit 3. Preparation of certification of Henry Dunant Hospital according to the specifications of OHSAS 18001 standard 1. Internal Audits based on the ISO– 9001:2000 and ΕLΟΤ 1416 standards 2. Maintenance of quality systems of ISO 9001 and HACCP and preparation of external audit 3. Preparation of certification of Henry Dunant Hospital according to the specifications of OHSAS 18001 standard



N.C.R.N.S. DEMOKRITOS

• Research Associate

  • Oct 2000 - Jul 2001

  1. Science research in the field of Microbiology and Molecular Biology 2. Genes’ analysis of an insect-pathogen fungus species that harms insects harmful for olive trees, with aiming to promote the ecological control of parasites 1. Science research in the field of Microbiology and Molecular Biology 2. Genes’ analysis of an insect-pathogen fungus species that harms insects harmful for olive trees, with aiming to promote the ecological control of parasites