Summary
Location: Amsterdam
As Clinical Research Associate you will be responsible for monitoring patient data & study-related information related to clinical study sites and clinical trial participation. Ensuring the investigator adheres to research protocols, regulatory requirements and good clinical practices and provides input into data validation plan. Providing timely and accurate monitoring of patient data and study-related information from source documents, research records, and site visits where applicable.
About the Role
Key Responsibilities:
- Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial
- Performs site Initiation Visit, ensures site personnel is 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 organization on specific projects
- Contributes to some cost center 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
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
- Distribution of marketing samples (where applicable)
Essential Requirements:
- Education: Degree in scientific or healthcare discipline plus relevant, related healthcare experience
- Languages: English and Dutch fluent spoken & written
- Previous experience in Clinical Research Associate role highly desirable.
- Central/in-house monitoring or field monitoring experience is desirable
- Decision capability. Excellent time management and organization capabilities
- Early adopter and open mindset across borders to support one study approach. Good knowledge of drug development process specifically clinical trial/research. Clinical and therapeutic knowledge. Knowledge of international standards. Understanding the purpose of the CRA
- Ability to manage sites independently; Proven ability to work independently with minimal supervision. Good analytical thinking. Ability to anticipate potential issues and take appropriate actions with or without supervision.
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
Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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/ne
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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
EEO Statement :
Learn about our business, strategy and performance in 2023, and how we create sustainable value for stakeholders and society.Learn about our business, strategy and performance in 2023, and how we create sustainable value for stakeholders and society.Learn about our business, strategy and performance in 2023, and how we create sustainable value for stakeholders and society.Learn about our business, strategy and performance in 2023, and how we create sustainable value for stakeholders and society.
Learn about our business, strategy and performance in 2023, and how we create sustainable value for stakeholders and society.Learn about our business, strategy and performance in 2023, and how we create sustainable value for stakeholders and society.Learn about our business, strategy and performance in 2023, and how we create sustainable value for stakeholders and society.Learn about our business, strategy and performance in 2023, and how we create sustainable value for stakeholders and society.
Learn about our business, strategy and performance in 2023, and how we create sustainable value for stakeholders and society.Learn about our business, strategy and performance in 2023, and how we create sustainable value for stakeholders and society.Learn about our business, strategy and performance in 2023, and how we create sustainable value for stakeholders and society.Learn about our business, strategy and performance in 2023, and how we create sustainable value for stakeholders and society.
