Clinical Research Associate

1 miesiąc temu


Warszawa, Mazovia, Polska Novo Nordisk Pełny etat

About the Role

As a Clinical Research Associate at Novo Nordisk, you will be responsible for verifying the accuracy and completeness of trial data, ensuring the rights and well-being of human subjects are protected, and ensuring the conduct of the trial follows the current approved protocol, GCP, and local legislations.

Main Responsibilities

  • Performing site selection, initiation, and conduct activities in compliance with local regulations, ICH-GCP, Novo Nordisk procedures, and protocol requirements to ensure data quality and study subject protection.
  • Supporting site recruitment and retention activities at the study level in close cooperation with the CDC Trial Manager.
  • Preparing payments, approving invoices, and assisting with audits and inspections at sites and in the affiliate.
  • Acting as an ambassador for the company and contributing to making Novo Nordisk the preferred partner, as well as establishing and maintaining professional relationships with all KOLs, internal, and external stakeholders.

Qualifications

  • Fluency in both English and Polish.
  • A valid driving license.
  • Academic degree preferably in Life Science or similar disciplines.
  • Experience in monitoring activities or equivalent.
  • Ability to build and maintain strong relationships and successfully cooperate with internal and external stakeholders, including KOLs.
  • Experience in taking ownership of tasks for site activation to ensure timely FPFV, coordinating, and driving these 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., ePRO, InForm).
  • Excellent communication and negotiation skills to cooperate easily even with difficult stakeholders.
  • Good decision-making and problem-solving capabilities and strong prioritization skills to meet tight deadlines.

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. 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 employees. Together, we go further. Together, we're life changing.



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