Study Start-Up Clinical Research Associate

Novartis Farmacéutica; France; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A leading pharmaceutical company is seeking a Study Start-Up Clinical Research Associate to manage start-up activities, ensuring adherence to regulatory standards and site readiness. The role emphasizes collaboration, problem-solving, and strong negotiation skills to navigate the clinical trial landscape effectively.

Prestations

Attractive salary range

Annual bonus

Career development focus

Quality of Life at work program

Advanced social coverage

27 days paid leave & 14 days RTT per year

Employee recognition programs

Qualifications

• Minimum 3 years’ experience in clinical operations.
• Advanced understanding of drug development processes, especially trial set-up.
• Ability to travel for site selections.

Responsabilités

• Collaborates with study teams to meet timelines and deliverables.
• Manages start-up activities at assigned sites.
• Acts as main contact for trial sites during submissions.

Connaissances

Negotiation

Problem Solving

Site Management

Interpersonal Skills

Formation

Degree in scientific or health discipline

Description du poste

Study Start-Up Clinical Research Associate

Job ID REQ-10053385

France

Summary

About the Role

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.
• 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
• 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.

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

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