Senior Clinical Research Associate (m/f)
Area of Responsibility
Senior Clinical Research Associate (m/f), Vienna, Austria
130,000! The average number of patients around the world that are actively participating in our clinical trials. As a member of our Trial Monitoring team you will play an active role in ensuring patients in Austria have access to our clinical trials and make a difference in their lives.
As a Senior CRA in Global Drug Development (GDD), you will perform monitoring activities related to site selection, initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV clinical trials within the country.
Your responsibilities include, but are not limited to:
• Performing Trial Monitoring Activities related to initiation and conduct (recruitment, quality data collection) as well as timely completion of phase I-IV oncology clinical trials within Austria in accordance with the monitoring plan and Novartis procedures.
• Delivering quality data within timelines and required quality standards. Adhering to monitoring procedures in compliance with ICH-GCP, local regulations and SOPs.
• Acting as the front-line liaison between Novartis and sites to ensure successful collaboration, meeting Novartis’ expectation on milestone and deliveries.
• Conducting site selection, evaluating site’s capabilities for conducting a clinical trial.
• Performing Site Initiation Visits, ensuring site personnel is fully trained on all trial related aspects.
• Collaborating with the Clinical Study Managers and CRA Manager to ensure recruitment plans and execute contingency plans, as needed
What you’ll bring to the role:
• Degree in scientific or healthcare discipline or equivalent.
• Minimum of 3 years’+ pharmaceutical industry experience particularly relating to clinical monitoring.
• Advanced understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), international health authorities (FDA/EMEA) and local/National Health Authorities regulations.
• Ability to travel domestically; a minimum of 50%, overnight travel may be required.
• Strong communication skills and team collaboration as well as leadership skills.
• Fluent in both written and spoken English and German.
• Excellent knowledge of drug development process specifically clinical trials/research/site management
• Project management skills
Why consider Novartis?
750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group.
The base pay is composed of the respective amount according to the Austrian collective agreement (at least €23.632.00 per year on a full time basis), plus a potential market oriented excess payment.
We are Novartis. Join us and help us reimagine medicine.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
Novartis Pharma GmbH Human Resources Stella-Klein-Loew-Weg 17 1020 Wien Austria