Clinical Operations Lead
Excelya
full-time
Posted on:
Location Type: Hybrid
Location: Paris • France
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Job Level
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About the role
- Lead and coordinate the operational aspects of assigned clinical studies, including study start-up, site management, and monitoring activities to ensure compliance with protocols and GCP standards.
- Act as the primary liaison between project teams and clinical sites, ensuring effective communication and collaboration.
- Oversee the planning and execution of monitoring visits, including preparation of visit reports and follow-up on findings.
- Train and mentor Clinical Research Associates (CRAs) and ensure they are aligned with project goals and objectives.
- Review study-related documents for accuracy and completeness, ensuring regulatory compliance throughout the study lifecycle.
- Support the management of study budgets and timelines, providing regular updates to project stakeholders.
- Ensure that site staff are knowledgeable about study protocols and GCP requirements through ongoing training and support.
- Facilitate problem-solving and risk assessment to address issues that may arise during the study.
Requirements
- Minimum of 5 years of experience in clinical monitoring and study management within a CRO or pharmaceutical company; prior experience as a CRA or in a lead role is highly desirable.
- Strong understanding of GCP, ICH guidelines, and regulatory requirements; excellent leadership, communication, and interpersonal skills; proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Bachelor’s degree in life sciences, medicine, or a related field; advanced degree is a plus.
- Bilingual in French, proficient in English; knowledge of additional languages is an advantage.
Benefits
- At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical monitoringstudy managementGCPICH guidelinesregulatory complianceclinical trial management systems (CTMS)electronic data capture (EDC)budget managementrisk assessmenttraining and mentoring
Soft Skills
leadershipcommunicationinterpersonal skillsproblem-solvingcollaboration