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.
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. 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
- Ensure efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set up.
- Support and ensure that all specific CRO EDC system
- Support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate in the organisation and preparation of the monitor and investigator meetings in collaboration with the other study team members
- Assist the GCPM/ study team in the evaluation of detailed timelines and establishment of clinical studies milestones for assigned projects, ensuring that they are performed to the most rigorous standards of quality and timely delivery.
- Validate the final clinical study documents (such as study manual, monitoring plan …) prepared by the Clinical CRO.
- Review all/a sample of site visit reports as per the Oversight Monitoring Plan
- If applicable, provide support and guidance to Internal CRAs (Corporate & Affiliates with provision of some supervision in specific cases).
- Coordinate and manage the CRO relationship, assisting CRO CRAs/CTLs when and where necessary.
- Co-monitor clinical studies according to the oversight monitoring plan
- Participate in the ongoing clinical study data reviews in collaboration with the other study team members.
- Ensure the agreed timelines for data collection (CRF/eCRF) and data clarifications/queries are met, sending information to data-management and monitoring CROs as appropriate.
- Maintain and review key documents required for Clinical Study Report (CSR), to ensure adequate quality (e.g. for CSR appendices publishing)
- Participate in the preparation and follow-up of any other study systems (such as IWRS/IMP forecasting/ flow etc…), as required.
