Clinical Operations Lead Early Phase Oncology

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 Pharmacovigilance. 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.

Main Responsibilities:

• Oversee CRO clinical teams to ensure efficient study start-up, including feasibility assessments, site selection, and timely completion of regulatory and ethics documentation.
• Ensure all site set-up and EDC-related clinical activities are completed on time and in compliance with defined timelines.
• Support and contribute to CRA training, as well as the preparation and delivery of investigator and monitoring meetings in collaboration with cross-functional teams.
• Assist the study lead and project team in defining study timelines, milestones, and deliverables, ensuring high-quality and timely execution.
• Prepare, review, and approve key clinical oversight and study documents (e.g. monitoring plans, study manuals, KPIs/KRIs).
• Monitor site performance and risk indicators, review monitoring reports, and ensure appropriate and timely follow-up of findings.
• Coordinate and manage CRO relationships, including oversight of CRAs/CTLs and participation in RFP and bid defense activities.
• Perform co-monitoring activities, contribute to study data reviews, and proactively identify and resolve operational issues.
• Ensure timely and accurate data collection, query resolution, and effective coordination of study samples and assessments across stakeholders.
• Conduct regular TMF quality reviews and support audit and inspection readiness and follow-up activities.
• Act as a company ambassador at investigator sites, building strong relationships while ensuring compliance with GCP, ICH guidelines, and internal SOPs.

Requirements

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 ability to thrive in collaborative, fast-moving environments (talent matters most to us!)
• Skills: Solid background as a Field CRA, with hands-on monitoring experience especially in Phase I studies, proven experience in CRO oversight, including coordination of study start-up, monitoring activities, and vendor management.
• Education: Life sciences or medical degree, or equivalent qualification
• Languages: fluent in English (written and spoken), French is 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.