Clinical Research Associate Lead - Oncology

Excelya; Paris; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

A dynamic health company in Paris is seeking an experienced Clinical Research Associate Lead specializing in Oncology. In this role, you will oversee clinical site lifecycles, draft study documents, and mentor a team of associates while ensuring regulatory compliance. Ideal candidates have significant experience in oncology trials and a Master's degree in life sciences. Proficiency in French and English is required.

Qualifications

• Proven experience as a CRA with at least 1–2 years in a lead or coordination role.
• Familiarity with TMF and CTMS systems.
• Proficiency in French and English.

Responsabilités

• Lead the full clinical site lifecycle for oncology studies.
• Draft critical study documents including monitoring plans and site manuals.
• Supervise and mentor a team of Clinical Research Associates.
• Ensure adherence to regulatory and operational compliance.
• Manage site communications regarding study progress.

Connaissances

Oncology clinical trials

Clinical Trial Management System (CTMS)

Trial Master File (TMF)

Risk-based monitoring

Quality assurance

Team coordination

Formation

Master's degree in life sciences or related field

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 is an exciting opportunity for an experienced Clinical Research Associate Lead specializing in Oncology to contribute to a dynamic team in Clinical Operations. You will play a crucial role in innovating clinical research practices in the oncology field, making a significant impact on the lives of patients.

Main Responsibilities

• Lead and oversee the full clinical site lifecycle for oncology studies (initiation, activation, monitoring, close-out) across all participating centers.
• Draft critical study documents like the Oncology Monitoring Plan, site manuals, and patient management guidelines.
• Supervise and mentor a team of Clinical Research Associates (CRAs), ensuring their professional development and effective monitoring practices.
• Ensure adherence to regulatory and operational compliance aligned with oncology protocols, SOPs, and ethical guidelines.
• Utilize tools such as the Clinical Trial Management System (CTMS) and ensure the integrity of the Trial Master File (TMF) for oncology studies.
• Manage site communications, providing updates on study progress, recruitment status, and protocol modifications specific to oncology.
• Contribute to oncology‑specific study setup activities including database design, risk assessments, and resource planning.
• Participate in centralized medical monitoring and review oncology-related protocol deviations and risks.
• Lead final close‑out efforts: quality checks, visit planning, and data archiving for oncology trials.
• Collaborate cross‑functionally within the organization and participate actively in departmental meetings related to oncology research.

Requirements

About You

At Excelya, taking audacious steps is encouraged, so we’re looking for individuals passionate about oncology and driven by innovation.

• Experience: Experience in oncology clinical trials is a plus.
• Skills: Proven experience as a CRA with at least 1–2 years in a lead or coordination role, familiarity with TMF and CTMS systems, in‑depth knowledge of risk‑based monitoring and quality assurance.
• Education: A scientific degree in life sciences, pharmacy, or related field (Master's degree or equivalent preferred).
• Languages: Proficiency in French and English.

Benefits

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

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.