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SMS-oncology

Quality Management System

As a CRO, SMS-oncology is committed to providing the highest possible quality service to its clients, to protecting the safety and confidentiality of the subjects enrolled in clinical trials and to guaranteeing the integrity, reliability and traceability of data collected for research purposes.

SMS-oncology has put in place a comprehensive Quality Management System (QMS) and has a detailed training program to allow personnel to conduct its business in accordance with the guidelines of the International Conference on Harmonization for Good Clinical Practice (ICH-GCP) and the European Clinical Trial Directive (EU CTD). The management team strives to comply with legislation, to follow best industry practices and to work in the spirit of continuous improvement.

Paul Mooney MSc, CCPM, RQAP-GCP, MRQA
Quality Manager

 

Paul has over 23 years' international experience in clinical trial management and quality assurance (QA). He has a multicultural background being originally from Ireland, born in France, educated in Belgium and England, and now living in the Netherlands. He studied Chemistry at the University of Brussels and Clinical Research at the University of Liverpool. He is certified in Business management, Project management, as a trainer and as a public speaker. Paul has qualifications in 5 languages (French, German, Italian, Spanish and Dutch). In addition, he is a “Certified Clinical Project Manager”, a “Registered Quality Assurance Person” and a “Member of the Research Quality Association”. Paul started his career in 1993 working all over Europe as a Clinical Research Associate (CRA) for ICON, a CRO based in Dublin. He subsequently worked as a Sr. CRA for SmithKline Beecham Pharmaceuticals and later as a Sr. CRA / Clinical Project Manager for Biotrin (Diagnostics) in Ireland. In 2000 he moved to Amsterdam to work at the European headquarters of the biotech firm Genzyme as Clinical QA Manager and was later promoted to Associate Director of QA for Europe.

Paul has been a freelancer since 2006. In “Clinical Operations”, he has had various managerial and/or operational roles with a variety of clients (pharma, biotech, devices, CRO). In QA, he has been involved in about 100 audits (sites, CROs, vendors) and helped companies manage their quality systems and audits. As a trainer, he has given dozens of courses on a variety of relevant topics (e.g. GCP, EU & US regulations, etc). In January 2013 Paul joined SMS-oncology as a consultant Quality Manager and has been responsible for the successful implementation and improvement of the quality system and processes ever since.

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