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.
We are currently looking for a Site Monitoring Lead.
(This is a permanent role for 1 FTE)
Responsibilities
Trial Preparation:
- Plan trial quality and risk monitoring/ mitigation as part of the Trial Team.
- Deliver Risk-based Site Monitoring approach and training for the trial. Accountable for the development of the operational Site Monitoring & Oversight plans.
- Develop and provide appropriate training of Site Monitoring to Clinical Trial Managers (CT Manager) and Clinical Research Associates (CRA).
- Participate in development of trial level documents.
- Behave as expert and consultant on Site management and monitoring topics.
- Integrate patient/site level feedback to the documents ensuring design with a focus on the patient.
- Participate in and contribute to global/regional and local Trial Team meetings, international/ regional / local Investigator Meetings.
- Timely responses to Site Management and monitoring questions from external and internal stakeholders (including Regulatory Authority/Ethics Committee)
- Facilitate communication and direction with CT Managers and CRO CRAs.
Trial Conduct:
- Monitor progress and oversee Site Management and Monitoring activities conducted by CRO partners during clinical trial conduct including adherence to ICH-GCP, and regulatory requirements, compliance with SOPs, trial protocol, trial quality management and Site Monitoring plans.
Including but not limited to:
- Issue management / oversight on trial level.
- Pre-identification of important protocol deviations from site issues/deviations
- Continuous review, risk identification, evaluation/ analysis and communication on a trial level as applicable.
- Maintain Risk-based Site Monitoring approach for the trial and update Site Monitoring plan and trial level documents.
- Conduct Site and Monitoring Oversight (including Site Monitoring Oversight Visits) according to plan, implement follow-up actions and escalation, as required.
Trial Close-out:
- Coordinate timely cleaning and delivery of clinical trial data with Trial Team and countries
- Support compilation and review of the quality section for the clinical trial report for site monitoring activities
