Clinical Research Associate

Clinical Research Associate

**Category**:Clinical Development

**Location**:Madrid, Comunidad de Madrid, ES

**The Position**
- In the role you will need to manage clinical trial sites at every stage of the clinical trial process to a high quality in accordance with the Company’s policies and procedures, relevant legislation and ICH GCP requirements whilst maintaining the standards of the Novo Nordisk Way.
- Among your main responsibilities will be:

- Working within the respective country with one or more clinical trials, representing the local team in the CDC trial team led by the CDC Trial Manager, when applicable.
- Being a primary point of contact between site staff and Novo Nordisk, act as an ambassador for the company and contributes to making Novo Nordisk the preferred partner in clinical trials.
- Contributing to or leading selection of sites, in collaboration with CDC and local colleagues such as Line Manager and Medical Affairs.
- Overall site management, including site monitoring and remote monitoring as applicable.
- Ensuring that trial site staff are properly trained to conduct the trial(s), providing necessary training and identify and flag any development areas and implement mitigations.
- Managing trial sites to meet patient recruitment and retention target, aimed at successful completion of the clinical programme.
- Close collaboration with relevant roles to ensure successful conduct of the trial, such as local Lead CRA, CDC Trial Manager, CDC CTA and local Line Manager

**Qualifications**
- Education: Bachelor's Degree level, life science or nursing qualification or equivalent (desirable)
- Basic GCP qualification
- Healthcare industry experience or customer serviced
- based employment.
- Previous experience of monitoring trials in accordance with ICH GCP methodology
- Knowledge of clinical trial methodology and clinical trials environment - ICH GCP, regulatory issues, SOPs
- Knowledge of drug development process
- Good working knowledge of electronic clinical trials systems - IMPACT, EDC, IWRS, electronic TMF
- Computer literacy and IT skills
- Agility, ambition, creativity, strategic vision, curiosity, leadership skills.

**About the Department**
- Join our dynamic Clinical Operations Team in Madrid, where we are committed to advancing clinical research and improving patient outcomes. Our department is responsible for running all clinical development activities, from initial planning of clinical trials to authority submission. We provide resources, processes, and competences to all development projects, ensuring process alignment and optimisation. With a focus on trial planning and execution, we foster a collaborative and supportive atmosphere, empowering our team members to make a meaningful impact.

**Working at Novo Nordisk**
- We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

**Contact**
- For further information please contact **Isabel Marcos Traper

**Deadline**
- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
- At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.