Who We Are

Susan McGoldrick

Susan has worked in the pharmaceutical and CRO industry for over 11 years in medium-sized and small biotech companies including a virtual pharmaceutical company specializing in developing treatments for psychiatric and neurological disorders where she gained an in-depth knowledge of drug development. Susan has valuable experience in attending meetings and presenting data at the FDA and EMEA, filing a New Drug Application with the EMEA, and designing and obtaining agreement on the overall development requirements for a lead Phase III compound with the FDA. Susan also has a wealth of knowledge in financial management, intellectual property management as well as legal and contractual issues specific to the pharmaceutical and CRO industries.

Susan is a member of the Institute of Chartered Accountants of Scotland and qualified with Ernst & Young. She has an honours degree in Accountancy from Stirling University. Susan is a member of the Institute of Clinical Research.

 

 

Fiona Duffy

Fiona has over 16 years’ experience, within the pharmaceutical and CRO industry working for large companies, then medium sized/small biotech companies. Her experience spans Phase I to Phase III, in North America and in Europe. She has worked in psychiatry and neurology for the last eight years. After a solid grounding in Clinical Research as CRA and then project manager, Fiona moved on to set up and direct a clinical operation and a project management team, with responsibility for overseeing all clinical trials as well as for CRO selection/management, Regulatory Affairs, Medical Writing, QA and SOPs. Fiona was a key member of high level management teams including those with responsibility for strategic development of a lead Phase III compound and submissions for marketing approval.

Fiona has an honours degree in Biochemistry/Immunology from Strathclyde University and a Post-Graduate Diploma in Information Technology and is a member of the Institute of Clinical Research.

 

 

J Mark Sanderson

Mark has 22 years experience within the pharmaceutical, CRO and medical device industries. His experience spans Phase I to Phase IV clinical studies and Mark has managed multinational clinical trial projects for pharmaceutical and biotech companies and for CRO's. Mark's responsibilities have included overseeing clinical trial programs, budgets and contract negotiations and his therapeutic experience covers CNS, oncology, gastroenterology, cardiovascular, endocrinology, genitourinary, musculoskeletal, respiratory disease, and anaesthesia.

Mark has a B.Sc. (Biology Major) from Stirling University and is a member of the Institute of Clinical Research.

 

 

Dr Crispin Bennett

Crispin has over 11 years' experience in the pharmaceutical industry in medium-sized and small biotech companies including a virtual pharmaceutical company specializing in developing drugs for CNS disorders where he gained an in-depth knowledge of CNS drug development. By working alongside Dr David Horrobin, an internationally renowned medical researcher and entrepreneur, he gained a wealth of knowledge on lipids and fatty acids. In addition, he has worked in top-level project and management teams developing key products, authored and contributed to a range of documents including peer reviewed published papers where his subject knowledge and ability to describe complex ideas in a clear, incisive manner were of major benefit. He has also worked on submissions for product marketing approval to the European and US regulatory authorities and has considerable experience of supplying scientific and business information to colleagues and research scientists.

Crispin has an honours degree in Animal Sciences from Reading University and has a PhD in Dairy Science from Glasgow University.

 

 

Amanda Harrison

Amanda has over 11 years' professional administrative experience at a senior level within the pharmaceutical and CRO industry and has invaluable experience in administering extensive, complex patent portfolios. She was also the Editorial Assistant for two peer review journals and Assistant Company Secretary for a small pharmaceutical company.

Amanda is an Associate (ACIS) of the Institute of Chartered Secretaries and Administrators (ICSA) and has an MSc in Administrative and Information Management from Napier University and a Bachelor of Arts from Stirling University.

 

 

 

Lesley Sexton

Lesley has 10 years clinical research experience within the pharmaceutical and CRO industry, at CRA and at Project Management level.

Lesley has experience in co-ordinating clinical trial activities from study set-up through to clinical study report for European and US clinical trials. Lesley started her career in Research and Development as a Molecular Biologist with Glaxo Welcome. She moved on to become a Clinical Research Scientist with Glaxo Welcome and then joined Chiltern International as a CRA covering all monitoring duties within a large heart/stroke endpoints study. Since 2001 Lesley has worked in CNS/Psychiatry as senior CRA then Clinical Project Manager for an emerging Pharmaceutical Company working on studies in depression and Huntington's disease.

Lesley has a background in Biochemistry (Bacterial Genetics, Dundee University) and a Post-graduate Diploma in Biotechnology. Lesley is a member of the Institute of Clinical Research.

 

 

Laura Tannahill

Laura has 5 years clinical research experience within the pharmaceutical and CRO industry at CTA level.

Laura has a degree in Biology (BSc. Hon. Stirling University) and is a member of the Institute of Clinical Research.

 

 

 

 

 

 

Jo Bowler

Jo has 3 years experience within the pharmaceutical and CRO industry at CRA level.

 

Jo has a degree in Biomedical Science (BSc. Hon. Liverpool John Moores University) and has a Ph.D. in generation and characterisation of monoclonal antibodies against bone-specific alkaline phosphatases from Liverpool University. Jo is a member of the Institute of Clinical Research.

 

 

 

 

Jean-Louis Disez

Jean-Louis has studied Clinical Research for 1 year and has experience of working as a Clinical Research Associate. Jean-Louis has a degree in Biology (Diplôme Universitaire de Technologie = University Degree in Technology, equivalent to an HND) from Brest University, and two degrees in Biological Imaging and Neurosciences (Maîtrise des Sciences et Techniques = Master in Sciences and Techniques, equivalent to a BSc Hons + Diplôme d'Etudes Supérieures Spécialisées = Degree in Specialized Superior Education, equivalent to an MSc) from Caen and Strasburg Universities.

Jean-Louis has relocated from Paris to join QCTR. He is fluent in French, Spanish and English and is a member of the Institute of Clinical Research.

 

 

 

Debbie Galea

Debbie has 5 years experience in Clinical Research working first as a Clinical Research Associate and then as Clinical Team Lead and Country Research Manager. Debbie set up and ran the Maltese Office of a large CRO and was the European Regional Team Lead for 8 countries. Debbie has worked on Phase II and III clinical studies in a number of indications.

Debbie has an Honours Degree in Communication from the University of Malta and a Diploma in Anatomy and Physiology from Oxford University. Debbie is fluent in Maltese, English and Italian. Debbie has re-located from Malta to join the QCTR team. Debbie is a member of the Institute of Clinical Research.

 

 

 

Ingrid Gerber

Ingrid has 14 years experience within the CRO industry as a CRA and previously worked as a Biological Technologist in Germany for thirteen years. Ingrid has monitored phase II to IV clinical studies and her therapeutic experience spans CNS, rheumatology, gastro-enterology and cardiology. Ingrid is experienced in training and mentoring Junior CRAs.

Ingrid is fluent in German and English and is experienced in written French and Spanish. Ingrid is a member of the Institute of Clinical Research

 

 

Nicola MacIntyre

Nicola has three years CRA experience within the CRO industry and has worked for eight years in the clinical research field. Nicola is experienced in all aspects of monitoring and has a thorough knowledge of UK Clinical Trial Regulations and ICH-GCP. Nicola has excellent communication and interpersonal skills and a good working knowledge of various MS packages, eCRFs, and Oracle Clinical and Clinical Trial Management Systems.
Nicola has a degree in Medical Biochemistry (BSc Ord, Glasgow University) and is a member of the Institute of Clinical Research.

 

 

Ruth Warren

Ruth is an experienced QA Auditor who has worked for eight years in clinical research and development within the CRO Industry. Ruth has conducted sponsor and vendor audits and overall audit experience includes Investigator Sites, Trial Masterfiles, Project Databases (and their development), Data Management activities, Safety Reporting, Final Study Reports and Staff Training Records. Ruth is experienced in SOP management, writing and review. Ruth has a degree in Biological Sciences (BSc. Hons University of Plymouth), is an Associate member of the British Association of Research Quality Assurance (BARQA) and a member of the Institute of Clinical Research (ICR).

 

 

Marjory Waters

Marjory has over 8 years administrative experience within the pharmaceutical and CRO industry as well as comprehensive experience in administering IT systems and providing user support. Marjory has also maintained an extensive science library and reprints archive. Marjory has an HND in Computing - IT Support and is responsible for ensuring QCTR's compliance with relevant IT-related legislation and maintaining professional standards.