Clinical Trial Assistant

Join Excelya , where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. We are looking for a Clinical Trial Assistant to support the successful planning, execution and oversight of clinical trials across regional and site levels.

This role plays a key part in ensuring operational excellence, regulatory compliance and effective coordination between internal teams, investigational sites and external stakeholders throughout the clinical trial lifecycle.

Key Responsibilities

Provide administrative and operational support for the planning, coordination, conduct, and reporting of clinical trials in compliance with ICH-GCP, local regulations, and company procedures. Maintain trial tracking systems and tools to ensure accurate oversight of trial activities, timelines, and reporting. Organize and coordinate local and global trial-related meetings, including logistics and documentation support.

Support document management activities by maintaining trackers and ensuring timely availability of trial-related documentation, including translations when required. Assist in the preparation and management of study documentation within electronic document management systems (EDMS). Coordinate interactions between document contributors and final reviewers to facilitate efficient document processing.

Serve as a key point of contact between clinical trial teams, investigational sites, and local vendors, ensuring effective communication and collaboration. Support the management and coordination of study-related supplies, such as investigational products and site materials. Maintain and oversee clinical trial systems and user access management, ensuring data accuracy, completeness, and consistency.

Monitor and resolve system queries while supporting continuous compliance and data quality standards. Contribute to the maintenance of Trial Master File (TMF) documentation and ensure inspection readiness through high-quality record management.

Requirements

Bachelor's degree, administrative qualification, or equivalent professional experience. Previous experience in clinical research, clinical trial coordination, clinical operations, or a related administrative role within the pharmaceutical, biotechnology, or CRO environment. Good understanding of ICH-GCP guidelines, Good Documentation Practices (GDP), and clinical trial regulatory requirements.

Strong organizational and document management skills, with the ability to manage multiple priorities simultaneously. Excellent communication and stakeholder management skills in an international and multicultural environment. Strong problem-solving, coordination, and follow-up capabilities. Proactive mindset with the ability to work independently and collaboratively within cross-functional teams.

Comfortable learning and working with clinical systems, databases, and digital tools. Advanced proficiency with Microsoft Office Suite (Excel, Word, PowerPoint, Outlook). Fluent English, both written and spoken.

Benefits

Why join us? At Excelya, we combine a passion for science with the enthusiasm of teamwork to redefine excellence in healthcare. Here's what makes us unique: We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience.

Our "one-stop provider" service model—combining full-service, functional service provider, and consulting—allows you to grow through diverse and stimulating projects. By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey.

Excelling with kindness means evolving in an environment that values your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission.