Clinical Quality and Training Specialist in Novo Nordisk Ljubljana, Ljubljana, Slovenia
Website Novo Nordisk
This job listing is about Novo Nordisk in Ljubljana, Ljubljana, Slovenia 2022 exclusively on jobizille.com
Are you a dedicated clinical trials professional with an analytical mind? Are you highly motivated by being able to make a difference to improving patients’ lives and you are passionate about quality? If yes, then you could be the Clinical Quality and Training Specialist.
As a Clinical Quality and Training Specialist, you will be responsible for cascading down the global quality focuses targets/areas to the CDC level, managing the risks and issues, providing guidance to the clinical team, and collaboration across functions within the CDC and between Affiliates/Regional/Global teams to achieve the quality objectives. As a Specialist, you will support Clinical Quality and Training Managers in preparing and executing CDC clinical quality and training plans.
Your main responsibilities will be:
- Conduct site quality visits and process checks on an ongoing basis to review and maintain good level of quality in CDC
- Analyse quality metrics and reports to provide insights and predictions on quality risks to leadership team
- Prioritize issues and risks applying RBQM principles and implement effective CAPA across CDC
- Act as a GCP and SOP expert within CDC and provide clarifications to questions from trial management teams
- Adopt innovative approaches in conducting or facilitating state-of-art trainings to stakeholders involved in the clinical trials
To be successful in this role, we expect you to have:
- Minimum Bachelor’s degree preferably in Life Sciences
- Minimum 3 years of relevant experience in clinical trial monitoring in a Pharmaceutical company or Contract Research Organization – preferably with previous exposure to quality control, process improvement, training
- Excellent knowledge of GCP and current European Clinical Trials Regulations
- Excellent computer literacy and general IT skills, including clinical trial systems and good knowledge of quality systems for clinical trials
- Fluent English verbal and writing skills
On a personal level, you should have an analytical mind, able to reason with facts and logic, have the ability to lead without authority and have high focus on quality and patients’ safety. You need excellent communication and negotiation skills to inspire actions across CDC countries to manage quality risks/issues. You need proven decision-making and problem-solving capabilities applying RBQM principles. In this role, ability to manage multiple priorities is crucial, as well as willingness to adjust quickly to new situations in a continuously developing environment. Experience in project and site management is strongly desirable. We are looking for someone who enjoys travels as job involves traveling – both domestic and international.
About the Department
CDC Poland is part of Region South East Europe, Middle East and Africa (SEEMEA) and is a new set-up of clinical organization in Novo Nordisk Poland, covering a group of 16 countries including Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, North Macedonia, Italy, Romania, Serbia, Slovakia, Slovenia and Poland. CDC Poland is responsible for conducting clinical trials across this group of countries, providing clinical trial management and administration support to adjacent Affiliates. CDC Poland is currently responsible for approximately 20% of global patients in Novo Nordisk clinical trials.
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.
Apply before 16 December 2022.
Company: Novo Nordisk
Vacancy Type: Full Time
Job Location: Ljubljana, Ljubljana, Slovenia
Application Deadline: N/A