Are you an experienced CRA looking for a new challenge in the medical device industry?
You will be primarily responsible for coordinating and performing all aspects of clinical monitoring in compliance with FDA regulations, ICHGCP guidelines, national and EU laws. You will support the successful and timely management of clinical trials. Your duties will include site management and site monitoring to ensure protocol and regulatory compliance. In addition, you will verify source documentation, evaluate data quality and safety reporting. You will be the key contact person for the project team and the hospital and you will communicate directly with the Competent Authorities and/or Ethics Committees, when required.
Requirements
- A University degree (minimum bachelor’s degree or equivalent) in a health profession, medicine, science and/or engineering field, or qualified nurse.
- Several years’ field monitoring experience working for a CRO, medical device or pharmaceutical company.
- Excellent clinical trial monitoring skills. Clinical Research Associate certification would be an advantage.
- Strong working knowledge and understanding of FDA, ICH-GCP, national and international laws/regulations governing clinical trials.
- High level of attention to detail and strong organisational ability.
- Willingness to travel extensively (overnight stays may be required).
- Excellent communication and interpersonal skills. Ability to work both independently and as part of a team.
Benefits
We offer an attractive salary and benefit package to employees. Positions may be office-based or home-office based, depending on your location. You will have the opportunity to work with a professional, open-minded, and highly motivated clinical trial team. We offer extensive education and training opportunities both internally and externally to strengthen your knowledge of cardiology and about our medical devices. If you share our fascination for the medical technology of the future, we look forward to receiving your application including up to date CV. Should you have any questions, please contact Catherine Lister either by phone or by e-mail.
About BIOTRONIK
We are one of the world’s leading producers of products and services for cardiac electrotherapy and vascular intervention, represented in more than 100 countries around the globe. More than 4,500 employees are engaged in research, development, production and marketing. In everything they do, our employees see themselves as the physician’s partner. With a high level of initiative and interdisciplinary cooperation, we succeed time and again in developing innovative technologies with unique therapeutic advantages.
Contact
Catherine Lister • Research Manager • Biotronik UK Ltd. • BiotronikHouse
Avonbury Business Park • Bicester, OX26 2UA • United Kingdom
Mobile: +44 (0) 7860 378962 • Office: +44 (0) 1200 440958
Mail: c.lister@biotronik.co.uk
