Clinical Operation Lead

About the Job

At Excelya, we embody Audacity, Care, and Energy in all that we do. We offer a dynamic and inclusive environment where innovation and collaboration drive success.

The Clinical Monitoring Lead will oversee and coordinate clinical monitoring activities to ensure the successful and compliant execution of clinical trials. This role involves leading CRA teams, ensuring quality standards are met, and maintaining effective communication with stakeholders to implement best clinical practices.

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.