Apply for CRA Role at Novartis

Spain Job Openings

Novartis

CRA

Madrid

FULL TIME

October 22, 2024

Summary

Supervisa los datos de los pacientes y la información relacionada con el estudio relacionada con los sitios de estudio clínico y la participación en los ensayos clínicos. Garantiza que el investigador se adhiere a los protocolos de investigación, los requisitos reglamentarios y las buenas prácticas clínicas y proporciona información sobre el plan de validación de datos. Proporciona un monitoreo oportuno y preciso de los datos del paciente y la información relacionada con el estudio de los documentos de origen, los registros de investigación y las visitas al sitio cuando corresponda. Pueden monitorear los sitios de estudio y la selección de instalaciones de auditoría.

About the Role

Main Accountabilities

Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset.
Manages assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects.
Conducts continuous site monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, ICH/GCP, global and local regulation including Health Authorities, IRB/EC, data privacy requirements, global and local processes as applicable.
Identifies deficiencies in site processes and monitor site processes performed outside the siteworks in close collaboration with site on risks mitigation and process improvements.
Promotes a compliance culture advocating adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times.
Identify deficiencies in site process, work in close collaboration with site on risk mitigation.
Early engagement with site on patient inventory and patient flow in advance of SIV in close collaboration with global and local study team.
Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements.

Experience/Professional requirement:

Up to 2 years pharmaceutical industry experience or other relevant experience
Central/in-house monitoring or field monitoring experience is desirable
Fast change adaptability to best partner & influencing with sites on fast changing landscape
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
Clinical and therapeutic knowledge knowledge of international standards (GCP/ICH, FDA,EMA)
Understanding the purpose of the CRA (Patient Safety; Data Integrity; PI oversight; GCP/ICH & Protocol Compliance)

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
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

Division

Development

Business Unit

Innovative Medicines

Location

Spain

Site

Madrid Provincial

Company / Legal Entity

ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

We regret to inform you that this job opportunity is no longer available as it has expired

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