Clinical Monitoring Lead Neurology
il y a 1 semaine
**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 Medical Writing. 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.
Take responsibility for coordinating the operational aspects of assigned studies, including, study start-up, regulatory submissions, and clinical site management & monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned international Phase I to III clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of quality, timely delivery and within budget, in order to assist in the delivery of Clinical Development objectives and achieve clinical excellence.
Coordinate the achievement of assigned clinical study deliverables within a matrix organization and the support of Global Clinical Project Managers (GCPM), Coach a matrix clinical team to manage the clinical study deliverables on a day to day basis.
**Requirements**:
- **Experience**: Solid background in clinical trial coordination and site management for global registrational studies, with mandatory oncology experience. Prior field monitoring experience (CRO or pharma) highly valued. Familiarity with CRO oversight and global clinical operations is a plus.
- **Skills**: Strong knowledge of GCP and ICH guidelines. Experienced in study documentation from set-up to close-out. Able to build productive relationships with external partners and internal stakeholders.
- **Education**: Degree in life sciences, medicine, or other relevant field.
- **Languages**: Full professional fluency in English (C1/C2); additional languages are a plus.
**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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