Clinical Operations Lead

Excelya; Paris; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A clinical research organization is seeking a professional to lead and coordinate clinical studies in Paris. The ideal candidate has a minimum of 5 years of experience in clinical monitoring and study management, with strong leadership and communication skills. This role involves acting as the liaison between project teams and clinical sites, overseeing monitoring visits, and mentoring Clinical Research Associates. A Bachelor’s degree in life sciences or medicine is required, along with bilingual proficiency in French and English.

Prestations

Innovation-driven work environment

Diverse project opportunities

Focus on personal growth and development

Qualifications

• Minimum of 5 years of experience in clinical monitoring and study management.
• Prior experience as a CRA or in a lead role is highly desirable.
• Bilingual in French and proficient in English.

Responsabilités

• Lead and coordinate the operational aspects of assigned clinical studies.
• Act as the primary liaison between project teams and clinical sites.
• Oversee the planning and execution of monitoring visits.
• Train and mentor Clinical Research Associates.
• Review study-related documents for regulatory compliance.
• Support the management of study budgets and timelines.
• Ensure site staff are knowledgeable about study protocols.
• Facilitate problem-solving and risk assessment during the study.

Connaissances

Strong understanding of GCP

Leadership skills

Excellent communication

Interpersonal skills

Proficiency in CTMS and EDC systems

Formation

Bachelor’s degree in life sciences or medicine

Description du poste

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

• Lead and coordinate the operational aspects of assigned clinical studies, including study start-up, site management, and monitoring activities to ensure compliance with protocols and GCP standards.
• Act as the primary liaison between project teams and clinical sites, ensuring effective communication and collaboration.
• Oversee the planning and execution of monitoring visits, including preparation of visit reports and follow-up on findings.
• Train and mentor Clinical Research Associates (CRAs) and ensure they are aligned with project goals and objectives.
• Review study-related documents for accuracy and completeness, ensuring regulatory compliance throughout the study lifecycle.
• Support the management of study budgets and timelines, providing regular updates to project stakeholders.
• Ensure that site staff are knowledgeable about study protocols and GCP requirements through ongoing training and support.
• Facilitate problem-solving and risk assessment to address issues that may arise during the study.

Requirements

About You

• Experience: Minimum of 5 years of experience in clinical monitoring and study management within a CRO or pharmaceutical company; prior experience as a CRA or in a lead role is highly desirable.
• Skills: Strong understanding of GCP, ICH guidelines, and regulatory requirements; excellent leadership, communication, and interpersonal skills; proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Education: Bachelor’s degree in life sciences, medicine, or a related field; advanced degree is a plus.
• Languages: Bilingual in French, proficient in English; knowledge of additional languages is an advantage.

Benefits

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here's what makes us unique—

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model — offering full-service, functional service provider, and consulting — enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient\'s journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.