Clinical Research Associate, CDC

Category:  Clinical Development and Medical
Location: 

Warsaw, Mazowieckie, PL

   

Are you a dedicated clinical trial professional with a direct site management experience? Are you highly motivated by being able to make a difference to improving patients’ lives? If yes, keep reading – this role might be just for you! 
 

The position
As Clinical Research Associate your role is to verify the accuracy and completeness of the trial data, that the rights and well-being of human subjects are protected, and the conduct of the trial follows the current approved protocol, GCP and local legislations.

 

Your main responsibilities will include:

  • Being the main point of contact between site staff and Novo Nordisk. Acting as ambassador for the company and contribution to making Novo Nordisk the preferred partner as well as establishing and maintaining the professional relationship with all KOL, internal and external stakeholders.
  • Supporting Site Management with the feasibility, selection, and initiation of sites as well as conduct and closing activities of the appointed studies in compliance with local regulations, ICH-GCP, Novo Nordisk procedures and protocol requirements to ensure data quality and study subject protection.
  • Assisting with audits and inspections at sites and in the affiliate
  • Supporting site recruitment & retention activities at the study level in close cooperation with the CDC TM
  • Excellence in off-site and on-site management activities including elements of Risk Based Monitoring

  
Qualifications
In order to be considered, you need to be fluent in both English and Polish and have a valid driving licence.

To be successful in this role, we expect you to have:

  • Academic Degree preferably in Life Science or similar disciplines
  • Min. 1 year of experience in direct site monitoring and performing all types of visits
  • Ability to build and maintain strong relationships and successfully cooperate with internal and external stakeholders including KOLs
  • Experience in taking ownership of start-up activities to ensure timely FPFV, coordinating and driving start-up activities in assigned trials, providing insightful input on local study start-up strategy and regulatory submissions documents and timelines
  • IT proficiency: MS Office, clinical trials systems (e.g. COSMOS / Veeva, IWRS, ePRO, CONNECT, HOT)

 

On a personal level, you should have the ability to lead without authority and have high focus on delivery and quality. You need excellent communication and negotiation skills to cooperate easily even with difficult stakeholders. You should have good decision-making and problem-solving capabilities and be strong in prioritizing task to meet tight deadlines. You should easily to new challenges in a continuously developing environment.

 

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

Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing.

 

Contact

If you believe you are qualified, and are willing to take the challenge, please send your CV directly via our online application tool.

We thank all applicants for their interest, however, only those candidates selected for interviews will be contacted.

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.

 

 

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