Thomas Naeschen
About Thomas Naeschen
Thomas Naeschen is a Senior Clinical Trial Manager at Boston Scientific with extensive experience in managing international cardiovascular device studies and expertise in regulatory standards and risk management.
Company
Thomas Naeschen currently works at Boston Scientific as a Senior Clinical Trial Manager. He has been part of the company since 2004, initially serving as a Clinical Project Manager. His tenure at Boston Scientific spans over 19 years, and he is based in Düsseldorf, North Rhine-Westphalia, Germany, working remotely. Previously, he held positions at various organizations including DATATRAK GmbH, MIMC, TAURUS Pharma GmbH, and Abbott Laboratories.
Title
As a Senior Clinical Trial Manager, Thomas Naeschen oversees complex clinical trials, with a focus on cardiovascular device studies. His role involves a wide range of responsibilities, from vendor selection to risk management and regulatory compliance. He also contributes to the global EDC Standards Committee, ensuring the development of standard CRFs across different study phases and departments.
Education and Expertise
Thomas Naeschen studied Biology at The University of Bonn, where he earned his PhD. His education between 1986 and 1996 has provided a strong foundation for his extensive career in clinical research and trial management. His expertise includes managing international studies, conducting First in Man (FIM) studies, vendor relationship management, and external training. He is well-versed in regulatory standards such as GCP/ICH, MDD/MDR, FDA CFR 21, and ISO14155:2020.
Background
Thomas Naeschen's professional journey began as a Sales Representative at Abbott Laboratories and TAURUS Pharma GmbH. He then transitioned into clinical research roles at MIMC and DATATRAK GmbH before joining Boston Scientific. Over the years, he has accumulated experience in various areas including risk management, study oversight tools, and the development of Standard Operating Procedures (SOPs).
Achievements
Thomas Naeschen has made significant contributions to his field, particularly in the management of international cardiovascular device studies. His work includes conducting First in Man (FIM) studies, developing oversight tools for Risk Based Monitoring (RBM), and participating in task forces to update SOPs and guidelines. His involvement in vendor selection and training on regulatory standards has been pivotal in ensuring the success and compliance of numerous clinical trials.