Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.
We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
What we offer:
- 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, ensuring adequate contact with investigator sites, identifying and solving issues in study progress, verifying data in-house or by conducting co-monitoring visits.
- Participate in the ongoing clinical study data reviews in collaboration with the other study team members.
- Make appropriate and timely reporting in CTMS.
- 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 TMF quality check review regularly to ensure adequate completion during the study course with a final thorough review at the end of the trial prior to study archiving
- Participate in the preparation and follow-up of any other study systems (such as IWRS/IMP forecasting/ flow etc…), as required.
- As appropriate, participate in the preparation of study documents and perform site visits prior to audits /inspection and assist in audit follow-up /findings resolution.
- Assist with the financial follow-up of the study, as required.
