lavori da Recherche Clinique in località United States

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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.

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 in Clinical Operations. 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

• Support and represent the Study Medical Manager in all study-related activities from setup to closure.
• Contribute to the development of trial-related documents, including protocols, informed consent forms (ICF), and amendments.
• Draft responses to medical queries from regulatory authorities, ethics committees, clinical sites, and study teams.
• Assist in the preparation and management of study committees, including member selection, charter development, and documentation.
• Maintain and organize medical and scientific documents in the Trial Master File (TMF).
• Conduct clinical case reviews, patient profile assessments, and validation of narratives.
• Collaborate closely with Trial Operations, pharmacovigilance, and statistics teams for data review and reporting.
• Review key study documents, such as risk management plans, CRFs, monitoring plans, and deviation lists.
• Contribute to the review of interim and final study reports, statistical tables, and clinical study reports (CSRs).
• Prepare for audits and inspections by ensuring compliance with medical review guidelines and regulatory standards.