Senior Clinical Research Associate

Vor 7 Tagen

Wien, Österreich Novartis Vollzeit

**Senior Clinical Research Associate (f/m/d), Novartis Pharma GmbH, Vienna, Austria (50-70% travel)**
650 This is how many patients were enrolled in Novartis clinical trials in Austria and managed by the Trial Monitoring Organization in 2021. 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 key responsibilities**:
Your responsibilities include, but are not limited to:

- Performing Trial Monitoring activities related to start-up, 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

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

**What you’ll bring to the role**:Essential**:

- 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 site engagement 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 Novartis?**
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying

**Imagine what you could do here at Novartis**

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 24,528.00/year (on a full time basis). We also offer a potential market oriented excess payment in line with your experience and qualifications.

**Commitment to Diversity & Inclusion**:Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.

**Division**

Global Drug Development

**Business Unit**

GDO GDD

**Country**

Austria

**Work Location**

Vienna

**Company/Legal Entity**

Novartis Pharma GmbH

**Functional Area**

Research & Development

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