Clinical Monitoring Lead oncology
il y a 3 jours
HybridOperations, Clinical Ops & eTMFFull time
Saclay, Île-de-France, France
OVERVIEW
Description
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. 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
Ensure the operational delivery of clinical studies from feasibility to site closure, in compliance with GCP, protocols, timelines, budgets, and allocated resources
Act as the main operational interface between Clinical Research Associates (CRAs), investigators, and global clinical and medical teams
Contribute to the preparation, review, and validation of study documents (protocols, ICF, CRF, etc.)
Coordinate financial aspects of clinical studies (vendors, contracts, budgets, invoicing)
Oversee CRA activities and provide scientific and technical support throughout the studies
Prepare and manage regulatory and administrative submission files in collaboration with CRO partners
Ensure study quality and scientific alignment, propose and implement corrective and preventive actions when needed
Support audits and inspections and contribute to continuous improvement initiatives
Organize and coordinate investigator meetings and investigator training sessions
Oversee pharmacovigilance activities and IMP management for assigned studies
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: Operational experience in the pharmaceutical industry or a CRO (excluding internships and short-term missions), Proven experience in oncology clinical trials (Phases I preferred; II–III a plus).
Skills: Strong knowledge of GCP and clinical research regulations, Ability to manage multiple projects in parallel and adapt to changing priorities.
Education: Degree in Pharmacy, Engineering, Life Sciences (Bachelor's or Master's level or equivalent)
Languages: French & English 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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