摘要
Location: Madrid: Provincial.
About the Role
Key responsibilities but not limited to:
- Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset
- Manage assigned study sites, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures
- Perform site initiation visits, ensures site personnel is fully trained on all trial related aspects.
- Perform continuous training for amendments and new site personnel as required.
- Conduct continuous site monitoring activities (onsite and remote).
- Implement site management activities to ensure compliance with protocol, global and local regulation including Health Authorities, data privacy requirements, global and local processes as applicable.
- Identify deficiencies in site processes and monitor site processes performed outside the site, works in close collaboration with site on risks mitigation and process improvements
- Promote 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
- Establish a strong partnership and true collaboration with the site, to increase patient density and decrease issues at site.
- Perform Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements
- Attend onboarding-, disease indication and project specific training and general CRA training as required
Essential criteria:
- Degree in scientific or healthcare discipline
- Up to 2 years pharmaceutical industry experience or other relevant experience Central / in-house monitoring or field monitoring experience is desirable
Desirable criteria:
- Decision capability
- Excellent time management and organization capabilities, including ability to prioritize and multi-task
- Risk based mindset (from issue management to risk identification) supported by Novartis systems
- 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 (GCP/ICH, FDA, EMA)
- Understanding the purpose of the CRA (Patient Safety; Data Integrity; PI oversight; GCP/ICH & Protocol Compliance)
Languages:
- Fluent in both written and spoken English and country language
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
