Hybrid Clinical Operations Lead – Neurology

at Excelya

• Job title: Clinical Operations Lead – Neurology
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Paris, France

About the role

• Clinical Monitoring Lead overseeing CRO activities for clinical trials at Excelya. Coordinating efforts across study phases while ensuring compliance and quality standards in a hybrid work environment.

Responsibilities

• **Main Responsibilities**
• Oversee and coordinate CRO clinical and site management activities throughout study start‑up, conduct, and close‑out phases.
• Ensure efficient and high‑quality study start‑up by reviewing feasibility assessments, supporting site selection, and verifying the timely collection of essential regulatory and ethics documents prior to site initiation.
• Support and ensure completion of sponsor‑specific clinical tasks within EDC, CTMS, and other study systems according to defined timelines.
• Support CRO teams in CRA training on study‑specific operational activities and participate in the preparation and organization of investigator and monitor meetings.
• Support Global Clinical Project Managers in defining detailed clinical timelines and study milestones, ensuring delivery to the highest quality standards.
• Prepare or contribute to monitoring oversight documentation, including monitoring plans, oversight plans, and clinical monitoring metrics.
• Customize, monitor, and follow site‑level KPIs and KRIs according to the monitoring oversight plan.
• Review and validate key clinical study documents prepared by CROs (monitoring plans, study manuals, operational documents).
• Review site visit reports (all or a defined sample) and ensure timely follow‑up and resolution of issues identified by CRAs.
• Coordinate and manage CRO relationships, providing operational guidance to CRO CRAs and CTLs as needed.
• Perform co‑monitoring visits and maintain direct contact with investigator sites to proactively identify and resolve study issues.
• Participate in ongoing clinical data reviews in collaboration with cross‑functional study teams.
• Ensure accurate and timely reporting in CTMS, with continuous quality checks.
• Ensure study samples and protocol‑required assessments are coordinated effectively between sites, CROs, vendors, and internal departments.
• Contribute to TMF quality reviews throughout the study and lead final TMF checks prior to study archiving.
• Support audit and inspection readiness activities, including site preparation and follow‑up of findings.
• Act as a backup to the Clinical Research Manager when required.
• Represent the sponsor at investigator sites and maintain strong, professional investigator relationships.

Requirements

• **About You**
• Experience as a **Lead CRA** or in a clinical monitoring leadership role coordinating international studies.
• Strong knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
• Excellent communication, organizational, and leadership skills.
• Ability to multitask, prioritize, and manage teams in a fast-paced environment.
• Degree in life sciences, pharmacy, nursing, or related field.
• Fluency in English and French is preferred.

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.