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.
Site Monitor II is responsible for making sure clinical trial data is accurate, high-quality, and follows all rules and guidelines (ICH GCP and local laws). Monitoring is done via on-site visits, with some remotely as needed. The role works closely with the Site Manager and other team members to ensure the site follows the study plan and is ready for inspections. It also involves regular contact with local investigators and institutions.
Main Responsibilities:
- Ensures regulatory, ICH-GCP, and protocol compliance. Evaluates site and staff performance, recommends site-specific actions, escalates key issues promptly, and develops action plans. Maintains current knowledge of ICH-GCP, regulations, and company SOPs/processes.
- Checks the site and external facilities, equipment supplies (clinical non-clinical) continue adequate conduct trial with their expiry dates (as applicable).
- Conducts source document review and verification or appropriate site source documents and medical records.
Beyond that, you will also be able to:
- Manage reporting of protocol deviations and appropriate follow up.
- Enter data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
- Conduct follow up for escalated adverse event monitoring (AEM) report query.
Moreover:
- Per the Clinical Monitoring Plan (CMP) or SMP : Ability to conduct monitoring activities using different methods (e.g., both on site and remote) where allowed by country regulations.
- For assigned activities : understand project scope, budgets, and timelines, manage site level activities and communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals and targets.
Requirements
At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.
• Experience: 3 years of clinical monitoring experience (virtual or onsite) is required.
• Skills: Effective communication with stakeholders, Adaptability to new technologies and processes, Problem-solving during process/system changes, Willingness to travel.
• Education: Bachelor’s degree or Science degree in a related field, or equivalent education/experience.
• Languages: Fluency in English language.
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.
Excelling with Care
At Excelya, Care lies at the heart of what we do. We provide equal opportunities for all and foster a diverse, equitable, and inclusive workplace where humility and boldness work hand in hand. Everyone has a space to feel valued, thrive, and collaborate with purpose.
Your challenges become our shared mission. Together, we transform bold ideas into reality—the Excelya way.
Apply today, become an Excelyate!
