817 million. That’s how many lives our products touched in 2018. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
The Senior Clinical Research Associate will support the goals of the GenMed organization by initiating, monitoring, and closing out clinical study sites following GCP and ICH guidelines as well as Novartis SOPs and ensuring that study milestones are met. Central point of communication between Novartis and investigational sites for all clinical trial related activities.
Your responsibilities include, but are not limited to:
• Manages assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures
• Conducts continuous monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety
• Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
• Ensures timely delivery, of high quality, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring. (ADIS, DBL)
• Identifies issues at sites; resolves issues and escalate as appropriate
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks. And where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help reimagine medicine.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
What you'll bring to the role:
• Bachelor’s degree in scientific or healthcare discipline
• Years of experience in site monitoring required -position to be filled at a level commensurate with experience:
CRA Level: Minimum of 2 years clinical research experience
Senior CRA Level: Minimum of 3 years experience in site monitoring
Expert CRA Level: Minimum of 5 years experience in site monitoring plus proven track record of leadership and monitoring excellence
• Excellent knowledge of the drug development process specifically clinical trial/research
• Ability to manage multiple priorities and manage time efficiently
• Good strategic thinking: Ability to anticipate potential issues and take appropriate actions with or without supervision
• Ability to manage sites independently; Proven ability to work independently with or without minimal supervision by direct
• A minimum of 50% overnight travel may be required
Global Drug Development
Research & Development