Anna Ntouflia

Clinical Team Manager (CTM) with extensive experience as a Clinical Research Associate (CRA) since 2017. Recently transitioned to CTM role after over 7 years in Functional Service Partnership (FSP) models for major pharmaceutical companies. Collaborated closely with clients and supported study management teams.

As an FSP-CRA, gained comprehensive exposure to all trial lifecycle stages, including Feasibility and Site Selection, Start-up activities, Contract preparations, Payments to sites, and participation in Sponsor and Investigator Meetings.

Mentored

Junior CRAs and served as a Trainer at CRA PPD Academy. Currently a team member of the EMEA Enrolment Task Force, contributing to patient recruitment and retention strategies. Worked on >14 clinical trials in different stages across various therapeutic areas, with significant experience in Oncology. Conducted all types of on-site and remote Monitoring Visits. Proficient in using various clinical and client-specific systems.

Clinical Team Manager in FSP - Thermo Fisher Scientific - Athens, Attiki, Greece

(2025-05)

Clinical team Manager Client dedicated with a role of Local delivery lead (LDL) responsible for delivering quality studies within assigned timelines by working in partnership with other internal and external stakeholders and by leading end-to-end study clinical operations (monitoring and site support) activities within their country or on occasion at an 'above-country' level. The LDL serves as the operational point of contact between the central Study Delivery Lead (SDL) and in-country operational staff aligned to study.

• Co-ordinate studies start up activities and requirements for regulatory and ethics reviews
• Lead / contribute to the development of key study documents
• Contribute to the development and maintenance of a Study Risk Plan & other study documents
• Forecasting and delivery of clinical trial materials
• Planning and conduct of investigator and country staff/monitor training sessions
• Represent the voice and perspective of the region/country at meetings

Senior Clinical Research Associate (Level I) - Thermo Fisher Scientific - Athens, Attiki, Greece

(2024-12 - 2025-04)

Clinical Research Associate (CRA) on four Interventional studies. Involved in all aspects of study preparations and conduction including but not limited to Contract preparation, Submissions to authorities, ICF customization etc. Performed feasibilities, PSV, SIV, IMV & COV visits according to Sponsor's SOPs & ICH GCP requirements.

• Mentoring Team Leader/ Trainer at PPD CRA Academy/ Monitor Accompanier - Assessments (MA) via the MAST Process
• Enrolment Task Force Team member

Clinical Research Associate (Level II) - Thermo Fisher Scientific - Athens, Attiki, Greece

(2022-05 - 2024-11)

Clinical Research Associate (CRA) on three studies. Involved in all aspects of a study preparations including but not limited to Contract preparation, Submissions to authorities, ICF customization etc. Performed feasibilities & SIV visits according to Sponsor's SOPs & ICH GCP requirements. In addition, supported team by setting up trackers/folders, assisted in foundation of a new department of an FSP Model for a Biopharma Partner.

Clinical Research Associate (Level II) in FSP - IQVIA - Athens, Attika, Greece

(2021-05 - 2022-04)

Clinical Research Associate (CRA) on four studies. Performed tasks including but not limited to feasibilities, PSV, SIV, IMV & COV Visits. Performed SDR and targeted SDV (Risk Based Monitoring) during on-site and remote visits using EDC and in-house local CTMS system for reporting.

Reviewed on-site Investigator files and ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow-up. Used IVRS/IWRS for IP set-up, accountability and management. Maintained regular site staff contacts, training and query resolution support.

Support in interim analysis and/or database locks.

Clinical Research Associate Sponsor Dedicated - Creative Pharma Services S.A. - Athens, Attiki, Greece

(2018-04 - 2021-04)

Sponsor Dedicated Clinical Research Associate (CRA) on five studies, phase IV Observational clinical studies in Respiratory (Asthma) and Metabolic (Diabetes Mellitus Type II) Disorders in adult subjects. Performed feasibility, site initiation, interim and close-out monitoring visits. Performed 100% SDV during on-site and SDR during remote visits using local EDC systems.

Reviewed on-site Investigator files and ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow-up. Maintained regular site staff contacts, training and query resolution support. Participated in interim analysis, Database Locks and audit preparations.

Trainee Clinical Research Associate - Creative Pharma Services S.A. - Athens, Attiki, Greece

(2017-10 - 2018-04)

As Clinical Research Associate Trainee provided support to experienced CRAs on phase II, III, IV, multi center studies in Ophthalmology, Neurology & infectious Diseases. Performed (co-Monitoring Visits (IMVs & COVs). Provided administrative and technical support to Project Teams.

M.Sc. - Microbiology - University of Northumbria (2014-09)

B.Sc. (Honors) - Biomedical Sciences - University of Northumbria (2013-07)

Animal Science - Agricultural University of Athens (2006-09 - 2009-06)