Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.
Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare. Further, Together.
Senior Clinical Research Monitor (CRA) Austria & Switzerland (m/f) - Home Office
You are attracted by the chance to work for one of the big players within medical devices and are interested to be responsible for a great and highly innovative as well as broad product portfolio?
Careers that Change Lives
The main purpose of this role is to be responsible for the oversight of clinical research conducted at investigational sites to ensure compliance with study protocols, applicable regulatory standards, IRB/EC policies and procedures and business requirements. This position works under minimal supervision, working closely with study teams, site personnel, Medtronic field personnel and monitoring supervisor for resolution of site issues. The Senior Clinical Research Monitor (m/f) may play a leadership role in overseeing monitoring activities and contributes as an experienced member of the clinical research team.
A Day in the Life
- Perform site monitoring visits in accordance with the study Monitoring Plan and Medtronic Standard Operating Procedures to ensure compliance with the Clinical Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, and Medtronic standards, guidelines and policies
- Communicate visit findings with site personnel and complete a written follow-up letter for distribution to the Principal Investigator and appropriate site personnel
- Prepare comprehensive site visit reports and correspondence for all visits
- Identify site needs and propose solutions to facilitate the clinical trial process
- Act as a primary point of contact for study sites
- Provide input into the development and improvement of investigator and site management systems
- Assist in conduct initial and ongoing site personnel training
- Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, Good Clinical Practices and Standard Operating Procedures
- Propose solutions and collaborate with monitoring management and study team personnel towards securing Investigator compliance
- Scientific degree (bachelor or preferably master) alternatively background as a nurse
- More than 3 years of experience in clinical research/clinical monitoring within Austria and ideally additionally within Switzerland
- Profound scientific knowledge, preferably within the medical devices industry, class III devices
- Good understanding of regulations and standards (e.g. Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive, etc.)
- Experience with Regulatory and Quality Assurance audits
- Fluent German and fluent English skills - written and spoken
- Excellent interpersonal and communication skills with the ability to develop strong professional relationships
- Experience working in a team/matrix environment requiring strong communication and working relationships
- Ability to handle and prioritize multiple therapeutic areas and projects simultaneously and to work in a fast-paced environment
- Experience working independently in a regional area with remote or minimal supervision
- Excellent problem solving skills, high attention to detail and accuracy
- Ability to travel up to 70%
Nice to Haves
- Experience in study submission to central and local ethics committees would be a strong advantage
- Additional French language skills would be a plus
- Experience within the product area cardiology
Is this the position you were waiting for? Then please apply directly via the apply button!
We offer you a salary package with a target income of minimum EUR 50,000 - with some flexibility, depending on qualification and experience.
Medtronic Österreich GmbH, 1200 Wien, Handelskai 94-96