Global Clinical Project Manager Rare Disease

<p><strong>About the Job</strong></p><p>Join Excelya, where <strong>Audacity, Care, and Energy</strong> 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.</p><p>This role is an exciting opportunity to contribute to a dynamic, ambitious team 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.</p><p><strong>Main Responsibilities</strong></p><ul> <li>Lead the <strong>global management</strong> of outsourced Phase II–III clinical trials, ensuring alignment with sponsor expectations, timelines, and quality standards. </li> <li> Act as the <strong>primary point of contact</strong> for internal sponsor teams and CROs, driving collaborative decision-making and proactive issue resolution. </li> <li> Review and validate <strong>project plans</strong> developed by CROs, including risk mitigation, escalation strategy, and communication plans. </li> <li> Oversee <strong>study budgets</strong>, monitor expenses, and ensure financial reporting in coordination with CROs and sponsor finance teams. </li> <li> Ensure trials are conducted according to <strong>ICH-GCP, SOPs, and applicable regulatory requirements</strong> across all geographies. </li> <li> Supervise <strong>cross-functional study teams</strong>, fostering coordination between Clinical Operations, Medical, Biometry, Pharmacovigilance, and CMC. </li> <li> Manage <strong>vendor and site relationships</strong>, including feasibility, selection, contracting, and performance follow-up. </li> <li> Review critical study documentation: protocols, CRFs, risk management plans, and recruitment strategies. </li> <li> Participate in <strong>audits and inspections</strong>, ensure CAPA implementation, and support continuous improvement initiatives. </li> <li> Contribute to <strong>study reporting</strong> and results publication in clinical registries, in compliance with transparency regulations.</li> </ul><p><strong>Requirements</strong></p><p><strong>About You</strong></p><p>At Excelya, <strong>taking audacious steps is encouraged</strong>, so we're looking for individuals who are ready to grow with us and share our values.</p><ul> <li> <strong>Experience:</strong> Proven ability to thrive in collaborative, fast-moving environments (avoid requiring minimum years—<strong>talent matters most to us!</strong>)</li> <li> <strong>Skills:</strong> Experience in <strong>global clinical project management</strong> in CRO, pharma, or biotech settings, Knowledge of <strong>clinical study lifecycle</strong>, regulatory expectations, and quality standards.</li> <li> <strong>Education:</strong> Master's Degree in a scientific, clinical, or research-related field</li> <li> <strong>Languages:</strong> French &amp; Fluent in English </li> </ul><p><strong>Benefits</strong></p><p><strong>Why Join Us?</strong></p><p>At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.</p><p>Here's what makes us unique</p><p>We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's <strong>leading mid-size CRO </strong>with the <strong>best employee experience</strong>. Our <strong>one-stop provider service model</strong>—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.</p><p><strong>Excelling with care</strong> 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</p>