Study Start-Up Clinical Research Associate

Key responsibilities:

• Collaborates with SSO Study Start-Up Team (Manager, Team Lead, and global study team) to meet Study Start-Up timelines and deliverables per country commitments.
• Manages start-up activities at assigned sites from country allocation to Green Light, including site selection visits and eligibility verification.
• Acts as main contact for trial sites during site selection, start-up, and submission preparation for IRB/IEC and Health Authority approvals.
• Prepares, collects, and finalizes country and site-specific documents (e.g., ICFs, CVs, GCP certificates) and supports the reduction of site-specific IRB/IEC deficiencies.
• Supports vendor setup and negotiates financial contracts and investigator payments in coordination with the SSU Manager.
• Updates internal systems and ensures inspection readiness by maintaining timelines, accuracy, and quality of country and site TMF documents.
• Ensures adherence to ICH/GCP, regulatory requirements, and Novartis financial standards while implementing efficient and innovative processes.
• Prepares for audits and inspections and ensures sites are ready for "Green Light," submitting approvals to the SSU Manager for review and final authorization.

Essential requirements:

• A degree in scientific or health discipline, preferably with clinical operations experience (or, for United States: 4-year degree plus relevant, related healthcare experience)
• Minimum 3 years’ experience in clinical operations in a monitoring / site management role
• Advanced understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
• Central/in-house monitoring or field monitoring experience is desirable
• Strong site management capabilities with demonstrated negotiating and problem-solving skills
• Advanced understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
• Strong interpersonal, negotiation and conflict resolution skills
• Ability to travel, e.g., for site selections, if applicable

You’ll receive:

• Attractive salary range
• An annual bonus
• A focus on your career development
• Access to our Quality of Life at work program
• Flexible working
• Advanced social coverage for you and your loved ones
• 27 days of paid leave & 14 days of RTT per year
• Various employee recognition programs

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.