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Novartis is hiring a

Clinical Research Associate

Amsterdam, Netherlands

Summary

Monitort patiëntgegevens & studiegerelateerde informatie met betrekking tot klinische onderzoekslocaties en deelname aan klinische proeven.. Zorgt ervoor dat de onderzoeker zich houdt aan onderzoeksprotocollen, wettelijke vereisten en goede klinische praktijken en levert input in datavalidatieplan. Biedt tijdige en nauwkeurige monitoring van patiëntgegevens en studiegerelateerde informatie uit brondocumenten, onderzoeksrapporten en sitebezoeken waar van toepassing. Kan studielocaties en selectie van auditfaciliteiten controleren.

About the Role

Key responsibilities:

  • Performs site selection for potential sites to evaluate their potential for conducting a clinical trial

  • Conducts site Initiation visit, ensuring site staff are fully trained on all trial-related aspects

  • Applies company policies and procedures to resolve a variety of issues

  • Frequent internal company and external contacts. Represents organisation on specific projects

  • Contributes to a variety of cost centre goals and objectives

  • Is the frontline liaison between Novartis and sites to ensure successful collaboration, site engagement and meeting Novartis expectation on milestone and deliveries

  • Notification of technical complaints / adverse reactions / special case scenarios related to Novartis products within 24 hours of receipt

Key Performance Indicators:

  • Monitors patient data & study-related information related to clinical research sites and participation in clinical trials

  • Ensures researcher adherence to study protocols, legal requirements and good clinical practice and provides input into data validation plan

  • Provides timely and accurate monitoring of patient data and study-related information from source documents, study reports and site visits where applicable

  • Monitor study sites and selection of audit facilities.

Essential requirements:

  • University Degree in Health Sciences

  • Fluent in Dutch and English (oral and written)

  • 3 – 5 years of experience in the role

  • Strong background in Clinical Monitoring and Clinical Research

  • Solid project management and communication skills

  • Drivers license

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network (link is external)

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