Study Start-Up Clinical Research Associate

Healthcare Businesswomen’s Association; France; Sur place; EUR 45 000 - 65 000; Plein temps

Résumé du poste

A leading company in healthcare is seeking a Study Start-Up CRA responsible for managing trial site activities, ensuring compliance with regulations, and facilitating study-specific start-up processes. The ideal candidate will have significant clinical operations experience and strong site management skills, contributing to successful trial launches.

Prestations

Attractive salary range

Annual bonus

Focus on career development

Quality of Life at work program

Flexible working

Advanced social coverage

27 days of paid leave & 14 days RTT

Employee recognition programs

Qualifications

• Minimum 3 years’ experience in clinical operations.
• Advanced understanding of clinical drug development.
• Strong interpersonal and negotiation skills.

Responsabilités

• Collaborates with the Study Start-Up Team.
• Manages start-up activities at assigned sites.
• Acts as main contact for trial sites.

Connaissances

Clinical Monitoring

Clinical Research

Collaboration

Decision Making Skills

Data Integrity

Clinical Trial Management Systems

Formation

Degree in scientific or health discipline

Description du poste

Job Description Summary

Site relationship management role to ensure sustainable trial start-up at Site.
The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs.

Job Description

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.

Skills Desired

Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences