Clinical Research Associate Lead

il y a 16 heures

Paris, France Excelya Temps plein

HybridOperations, Clinical Ops & eTMFFull time
Paris, 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 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**:
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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