Site relationship management role ensuring sustainable trial start - up for assigned sites in clinical drug development at Novartis. Collaborating with global teams and ensuring adherence to clinical operations standards and timelines.
About the role
- Senior Clinical Research Associate handling site monitoring for clinical trials in Italy. Ensuring protocol compliance and providing leadership in clinical trial management.
Responsibilities
- Conduct site monitoring responsibilities for clinical trials
- Provide oversight, leadership, and guidance in the management and execution of clinical trials
- Ensure protocol compliance, address site questions, and assist with study recruitment
- Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed
- Ensure integrity of CRF data through meticulous and thorough source document review and verification
Requirements
- BS/BA from a n undergraduate program (life sciences or related discipline preferred)
- 3 years of experience in the pharmaceutical / biotechnology / CRO industry
- 2 years of clinical monitoring experience with 1 year of management experience
- Minimum 2 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry (for EU)
- Ability to autonomously manage monitoring activities
- Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 (for EU)
- Strong command of English, both written and verbal (for US)
- Strong command of Local language, both written and verbal, in the country where monitoring activities are performed (for EU)
Benefits
- Professional development
- Global travel
- Flexible work programs
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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