Experience

Bioiatriki Healthcare Group

• Greece
• Hospitals and Health Care
• 400 - 500 Employee

• Clinical Research & B2B Manager

  • Oct 2022 - Present



Excelya

• France
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Head of Clinical Operations

  • Nov 2020 - Mar 2022

  - Lead the local Clinical Operations Team (up to 82 employees) and Activities. - Direct Line supervisor for the Line Managers, Feasibility & Offers Manager, Investigator Sponsored Studies Specialist, Project / Systems Coordinator & Training Coordinator and indirect for the Clinical Research Associates (CRAs), Study Start-up Specialists & Clinical Trial Assistants (CTAs). - Ensure that clinical trials allocated to the Country are conducted within the agreed timelines, quality and budget (approx. 5 million euros per year). - Represent Excelya with regulatory authorities and institutions - Enhance Excelya’s activities and profitability - Co-operation with other Excelya Clinical Research subsidiaries and affiliates, as so needed, in order to promote its interests. - Co-operation with relevant staff in the development of cost proposals to the clients and participation in proposal meetings with potential clients.



Boehringer Ingelheim

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Head of Clinical Operations Dept

  • Sep 2009 - Jun 2020

  - Line supervisor for the Clinical Trial Managers (CTMs), (senior)Clinical Research Associates (CRAs/senior CRAs), Clinical Project Assistants (CPAs) & BOS Project Manager (BOS PM) - Lead the local Clinical Operations Team (up to 17 subordinates) and Activities (TAs: Alzheimer’s Disease, Cardiovascular, CNS, Diabetes, Diabetes Implications, Immunology, IPF / ILD, Oncology, Respiratory). - Ensure that clinical trials allocated to the Country are conducted within the agreed timelines, quality and budget. - Coordinate the implementation of the FSP model (Functional Service Provider) on a Country level. - Enhance Clinical Operations partnerships with Patients Associations Groups – Primary contact person of the local company with PAGs for pipeline therapeutic areas. - Supervise the management of local vendors (e.g. CROs, Diagnostic Centers, Archiving facility, Drug Storage & Destruction facility). - Support matrix supervisor in daily management and development of the team members. - Supervise the execution of the Clinical Operations activities on a Country level in line with the MIDI strategy. - Represent the company in the Local Pharmaceutical Companies Association (SFEE).



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance Manager & Local Trainer

  • Mar 2008 - Sep 2009

  - Ensured the Qualitative conduct of Clinical Trials & the appropriate Training of the Clinical Operations Department staff.- Evaluated the participating Sites/Investigators, the CRAs and the Study Managers, by conducting co-monitoring visits & checks of the TMFs.- Reviewed, Updated & Drafted the Local SOPs.- Managed the Financial & Legal issues of the Clinical Operations Department- Acted as the primary contact person with the Hospitals’ District Authorities (YPE) & the Universities.

• CRA Manager

  • Nov 2004 - Mar 2008

  - Supervised 5-6 CRAs & Managed the conduct of Phaze II & III trials in Hepatitis, HIV, Herpes, Sepsis, Urology, Migrain, Anaesthesiology, Infectious Diseases, Gastroenterology, Pain, Dermatology, CNS, Pulmonary Diseases, Diabetes, Phychiatry, Cardiovascular Diseases.- Managed the Financial & Legal issues of the Clinical Operations Department- Acted as the primary contact person with the Hospitals’ District Authorities (YPE) & the Universities

• Senior Clinical Research Associate

  • Jul 2001 - Nov 2004

  Same responsibilities with the position of CRA Manager.

• Clinical Research Associate

  • Nov 1998 - Jul 2001

  Monitored the implementation of all activities related to the conduct of phase III Clinical trials, ensuring their timely and smooth completion, in line with company quality standards (SOPs), local laws and good clinical practice.