Clinical Project Manager managing Class II and Class III medical device clinical trials for Cochlear. Leading teams and ensuring compliance with regulatory standards in a hybrid work environment.
About the role
- Lead international clinical operations for innovative CRO, Excelya. Drive study strategies and ensure compliance while fostering team collaboration and project success.
Responsibilities
- **Main Responsibilities**
- Lead the strategy and oversight of international clinical operations for multiple studies across various indications.
- Coordinate with regional teams to ensure alignment on project objectives and timelines.
- Drive the planning and implementation of clinical studies in compliance with global regulations and company standards.
- Manage relationships with CROs and other vendors to ensure best practices and efficient study execution.
- Facilitate cross-functional collaboration to address project challenges and optimize resource allocation.
- Monitor study progress and quality metrics, implementing risk management strategies as necessary.
- Provide mentorship and guidance to clinical operations staff, fostering professional development and knowledge sharing.
- Prepare and present project updates to stakeholders and senior management, ensuring transparency and accountability.
Requirements
- **About You**
- At Excelya, **taking audacious steps is encouraged**, so we're looking for individuals who are ready to grow with us and share our values.
- **Experience:** Proven experience in monitoring activities (avoid requiring minimum years—**talent matters most to us!**)
- **Skills:** Strong organizational abilities, strategic thinking, and excellent communication skills. Expertise in regulatory compliance and ICH-GCP.
- **Education:** Master's degree in a relevant field.
- **Languages:** Fluency in French and English is mandatory.
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
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