Clinical Research Associate, CDC

1 tydzień temu

Warszawa, Mazovia, Polska Novo Nordisk AS Pełny etat

Are you a dedicated clinical trial professional with solid 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. As a CRA, you will be representing Novo Nordisk and being the main point of contact between site staff and Novo Nordisk.

Your main responsibilities will include:

Performing 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 Supporting site recruitment & retention activities at the study level in close cooperation with the CDC Trial Manager Risk Based Monitoring – excellence in off-site and on-site management activities Preparing payments, approving invoices, and assisting with audits and inspections at sites and in the affiliate 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

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 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 the 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. IMPACT, IWRS, ePRO, InForm)

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 tasks to meet tight deadlines. You should easily approach to new challenges in a continuously developing environment.

About the department

CDC Poland is part of Region Southeast 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.

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