About

Mag. Dr. Elisabeth Scheidl

Elisabeth Scheidl is an expert in clinical research with many years of experience (since 2000). Her strong understanding of high-quality requirements and her ability to think in a process-oriented and interdisciplinary manner have led her to specialize professionally in the area of quality assurance and quality management. She has been working in quality assurance for 15 years now, the last few years in senior management positions.

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Master’s degree in Life Science (Biology/Zoology) as Magistra rer. nat. at the University of Vienna, Austria

Graduation in Health Science (Medicine/Pharmacology) as Dr. rer. medic. at the University of Cologne, Germany

Master’s degree in EU Regulatory Affairs as MSc at the University for Continuing Education, Krems/Donau, Austria 

Certified Data Protection Officer acc. to EU GDPR 2016/679

After 9 years of operational work in various roles on the sponsor and CRO side, Elisabeth Scheidl switched to quality assurance as a quality assurance manager and auditor. After just over 3 years as an employee in quality assurance, she took on senior management roles in internationally operating organizations with a multinational team in up to 5 countries (Europe and North America).

In her last job, in addition to strategic tasks as Vice President Quality Assurance & Regulatory Affairs, she also took on the general management of the newly founded branch of a non-profit LLC in Germany.

Elisabeth Scheidl is a trained biologist and completed a master’s degree in biology/zoology at the University of Vienna. She completed her doctorate in health science (rer.medic.) in 2020 at the Center for Pharmacology at the Medical Faculty of the University of Cologne.

In addition to the above-mentioned academic training, Elisabeth has completed numerous professional training courses and qualifications, such as “Practical GCP Compliance, Auditing of Trials & Systems” from the DIA in London, UK, training as a compliance officer through the Management Circle in Berlin, Germany, an MSc in the EU Regulatory Affairs at the University for Continuing Education in Krems/Donau as well as certification as a data protection officer according to the GDPR by WiFi in Vienna, Austria.

Elisabeth is a member of the German Quality Management Association e.V. (GQMA) and Arbeitsgemeinschaft für Angewandte Humanpharmakologie e.V. (AGAH).

Elisabeth Scheidl has developed her people skills to be a strong and managerial leader with employees and colleagues. Her communication with management is always proactive in order to enable timely and targeted changes and adjustments to strategies and systems. In addition, she is well-organized, and her work ethic is focused on always meeting schedules and delivering excellent quality. She also participated in successful set-up of clinical trial sites from scratch, including the implementation of processes and training of the clinical trial staff on ICH GCP, respective laws and regulations, data protection matters, GDPR etc. Over the years, she has gained extensive experience in quality assurance and management of respective systems, risk management, as well as conducting all different kind of audits and managing audit programs.

How can my experience be of service to you?

ESC Elisabeth Scheidl Consulting provides tailor-made and flexible solutions for your quality and compliance management systems.

Further information about quality assurance, consultancy and training and auditing services can be found here:

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