Clinical Monitoring Lead oncology

Excelya Group; Saclay; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A dynamic clinical research organization in Saclay is seeking an operational expert to manage clinical studies effectively. You will ensure compliance with GCP and oversee project financials while coordinating with various stakeholders and teams. Ideal candidates should have substantial operational experience in the pharmaceutical sector, particularly in oncology trials, and possess strong knowledge of clinical research regulations. We value candidates who are adaptable and can manage multiple projects in a fast-paced environment.

Qualifications

• Operational experience in the pharmaceutical industry or a CRO, excluding internships.
• Proven experience in oncology clinical trials (Phases I preferred; II–III a plus).
• Fluent in French and English.

Responsabilités

• Ensure operational delivery of clinical studies in compliance with GCP and budgets.
• Act as the interface between CRAs, investigators, and medical teams.
• Coordinate financial aspects of clinical studies.

Connaissances

Knowledge of GCP and clinical research regulations

Ability to manage multiple projects

Adaptability to changing priorities

Formation

Degree in Pharmacy, Engineering, Life Sciences

Description du poste

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.

About You

• 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.

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to define 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 benefitting 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.