Summary
Overview
Work history
Education
Skills
Accomplishments
Languages
Timeline

SMARAGDA AGATHOU

Romford

Summary

An articulate, confident, and results-oriented individual, who has good knowledge of setting up, planning, and managing clinical Trials. A good communicator who gets along with colleagues and other stakeholders and enjoys working in a fast-paced environment. Having an active commitment to continuous improvement and comfortable working in a sustained growth-orientated work environment.

Overview

11
11
years of professional experience

Work history

GLOBAL TRIAL MANAGER

IQVIA
Remote work
01.2023 - Current
  • Point of contact for all queries received from global participating sites (more than 30 Countries worldwide)
  • Liaised with five different vendors, ensuring the smooth transition of the study.
  • Participated in meetings with various stakeholders and vendors globally, by answering and delegating queries about the study.
  • Ensured that all documentation was to the highest standard.
  • Supported the PLD Department (Project Level Documents) by data mining and updating regulatory documents (DSUR, PSUR, IB, MAPs (Managed Access Programs) and IITs (Investigator Initiated Trials) before the deadline.
  • Organised a successful virtual Investigator’s meeting with only 45 days prior notice, with an attendance of 600 people (Globally).
  • Core member of the global cross-functional Clinical Trial Team (CTT), participated and reported about on the study progress and issues/resolution plan at the CTT meetings.
  • Organised and wrote CTT meeting minutes being reviewed and amended by all the core members of the CTT Team.
  • Amended Vendor manuals to ensure the correct updated information was captured.

Senior Clinical Trial Coordinator

for Neuromuscular Diseases, CNMD
London
02.2020 - 01.2023
  • Line Managed the Clinical Trial Assistant, by arranging 1:1 and ensuring the workload was manageable.
  • Completed Risk Management for UCL Sponsored studies.
  • Set up and coordinate clinical trials, either sponsored by pharmaceutical companies or investigator-led.
  • Responsibilities include negotiating costing and contracts for studies, reviewing and submitting amendments and other study-related documentation to UCLH R&D and Ethics Committees.
  • Prepared submission of Orphan Drug Designation Applications to EMA for change of sponsorship and also submitted Annual Progress Reports for Orphan Drug Studies.
  • Created and maintained systems that capture specific activities such as overseeing expenses and payments.
  • Prepared Annual Progress Reports for the CNMD Studies and created/submitted Substantial Amendments to all the regulatory authorities in coordination with main Researchers.
  • Prepared SIV presentations for the Chief Investigators.
  • Archived 55 studies and created systems, capturing the correct archiving process.

Clinical Trial Coordinator

Dementia Research Centre, UCL
London
04.2016 - 02.2020
  • Set up commercially sponsored clinical trials.
  • Reviewed and negotiated costing and contracts for all commercial trials.
  • Reviewed amendments, protocols, and other study-related documentation.
  • Created and maintained systems capturing specific activities such as overseeing patient expenses and payments from commercial companies.
  • Reviewed the income received in the Departmental Account and raised inconsistencies to the finance department.
  • Organised monthly meetings with the Finance Department to discuss the income received.
  • Produced annual forecasting and financial reports, ensuring the potential hiring of new team members.
  • Liaised with consultants to discuss potential new studies.
  • Monitored and audited DRC research studies.
  • Reported the results and prepared presentations to the teams.
  • Prepared and submitted applications to REC and the R&D Department.
  • Prepared Annual Progress Reports and Study Closure Reports for the studies.
  • Reviewed and submitted Substantial Amendments to all the regulatory authorities.

Portfolio Coordinator

University College London Hospitals
London
07.2014 - 04.2016
  • Responsible for the Non-Commercial - Harmonisation studies, consisting of a portfolio of 150 Non-Commercial studies.
  • Completed global checks and coordinated with other departments (costing, contracts, Division Officers, sponsors, and CI) by ensuring that everything was completed prior to the submission deadline.
  • Reviewed non-CSP studies (sponsored or hosted), by ensuring that the paperwork (protocol, PIS, ICFs, and the IRAS forms) have been reviewed and correctly submitted to Ethics.
  • Communicating with PIs and researchers throughout the process, by explaining the next steps, andensuring that they felt valued and understood.
  • Reviewed amendments for hosted and sponsored studies.

CSP & Ethics Facilitator

Barts Health NHS Trust
London
05.2013 - 07.2014
  • Reviewed sponsored and hosted studies.
  • Communicated with Researchers and PIs, arranging meetings to answer questions and advise on the next steps.
  • Ensured that study documentation was to the highest standard, and correct before Ethics submission.
  • Assisted in the study costing and contract review.
  • Reviewed amendments for hosted and sponsored studies.

Education

GCP Certificate -

Online
09.2022 -

MSc (HONS) - Clinical Drug Development

Queen Mary University
2020

MA - Applied Translation (English - Greek

Metropolitan University
2010

MA - Design for Interactive Media

Metropolitan University
2006

Skills

  • Interpersonal skills
  • Detail orientated
  • Ability to multitask
  • Organisational skills
  • Time management
  • Problem solver
  • Ability to learn new software
  • Coordination
  • Schedule development
  • Budget analysis
  • Excel proficiency

Accomplishments

  • Organised a successful virtual Investigator's meeting with only 45 days prior notice, with an attendance of 600 people (Globally)
  • Answered queries and being point of Contact of more than 30 countries daily
  • Being a core member of the global cross-functional Clinical Trial Team (CTT), I participated and reported about study progress and issues/resolution plan at the CTT meetings;
  • Organised and wrote CTT meeting minutes being reviewed and amended by all the core members of the CTT Team
  • CENTRE FOR NEUROMUSCULAR DISEASES - CNMD:
  • Successful set -up of nine Commercial Trials
  • Reviewed and negotiated the budget for nine Commercial Trials
  • Negotiated and received money from commercial companies for the salary of a Band 7 Coordinator during a year
  • This has been the highest amount achieved for the past decade in the department
  • Reviewed and submitted to REC/HRA eight UCL Sponsored studies
  • Assisted and submitted in the submission of four grant applications
  • Created and submitted five substantial amendments for the department.

Languages

English
Fluent
Greek
Native

Timeline

GLOBAL TRIAL MANAGER - IQVIA
01.2023 - Current
Online - GCP Certificate,
09.2022 -
Senior Clinical Trial Coordinator - for Neuromuscular Diseases, CNMD
02.2020 - 01.2023
Clinical Trial Coordinator - Dementia Research Centre, UCL
04.2016 - 02.2020
Portfolio Coordinator - University College London Hospitals
07.2014 - 04.2016
CSP & Ethics Facilitator - Barts Health NHS Trust
05.2013 - 07.2014
Queen Mary University - MSc (HONS), Clinical Drug Development
Metropolitan University - MA, Applied Translation (English - Greek
Metropolitan University - MA, Design for Interactive Media

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SMARAGDA AGATHOU