Clinical Research Manager: Country Trials & Compliance Lead

FTFRA Fortrea France SARL; Paris; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Fortrea France SARL is seeking a senior country operations specialist to oversee local clinical trial activities, ensure regulatory compliance, and build relationships with investigators and external partners. The role requires leadership across cross-functional teams and strong project oversight in a country setting.

The candidate will coordinate with Country Research Director and Therapeutic Director, ensuring adherence to global policies while maintaining local regulatory standards and trial

Qualifikationen

• Thorough knowledge of ICH Guidelines and GCP and regulatory requirements.
• Thorough understanding of the drug development process.
• Fluent in local language and in English, both written and verbal.
• Strong leadership, communication, and collaboration skills.

Aufgaben

• PERFORMANCE - Accountable for performance and compliance for assigned protocols per ICH/GCP and country regulations.
• MANAGEMENT - POC for assigned protocols; drives execution and tracks timelines and results.
• QUALITY OVERSIGHT - Oversees quality and compliance; manages training and monitoring.
• EXTERNAL CUSTOMER FACING - Collaborates with vendors, investigators, and external partners; oversees site recruitment.
• INTERNAL COLLABORATION and STRATEGY - Aligns with PV, Regulatory, GMA/GHH; supports local strategy.
• All other duties as needed.

Kenntnisse

Clinical research

GCP/ICH knowledge

Regulatory compliance

Leadership

Stakeholder management

Communication skills

Multi-tasking

Decision making

Ausbildung

University/college degree (life science preferred)

Jobbeschreibung

Fortrea France SARL is seeking a senior country operations specialist to oversee local clinical trial activities, ensure regulatory compliance, and build relationships with investigators and external partners. The role requires leadership across cross-functional teams and strong project oversight in a country setting.

The candidate will coordinate with Country Research Director and Therapeutic Director, ensuring adherence to global policies while maintaining local regulatory standards and trial