Senior Clinical Research Associate
Novartis
Vienna, Austria
vor 5 Tg.

Job Description

Senior Clinical Research Associate (m / f), 50% Travel, Vienna, Austria

800 patients have been enrolled in Novartis clinical trials in Austria and managed by the Trial Monitoring Organization in 2019! Developing high quality products is one of Novartis' most important focus.

Our patients rely on us to deliver the quality, safety and effectiveness they deserve.

We are looking for you to enrich and strengthen the Trial Monitoring team in Austria. As a member of the TMo Organization in Vienna, you promote a culture of learning, continuous improvement and troubleshooting to ensure highest quality standards are met.

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 :

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 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 deliverables.
  • 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 are met and execute contingency plans, as needed
  • Minimum requirements

    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.
  • Desirable requirements :

  • Excellent knowledge of drug development processes specifically with regards to 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 the following : 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 are empowered to risk to fail 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, 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.

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