Clinical Monitoring Lead

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 900 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.

Key Activities :

• Take responsibility for coordinating the operational aspects of assigned studies, including, study start-up, regulatory submissions, and clinical site management & monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned international Phase I to III clinical studies in accordance with regulatory requirements,
• Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of quality, timely delivery and within budget, in order to assist in the delivery of Clinical Development objectives and achieve clinical excellence.
• Coordinate the achievement of assigned clinical study deliverables within a matrix organization and the support of Global Clinical Project Managers (GCPM),
• Coach a matrix clinical team to manage the clinical study deliverables on a day to day basis.

Profile :

• Experience of minimum 2 years of CTM / Lead CRA e.g. coordination of clinical activities/site management activities for the set up and running of international registrational studies (multiple sites/countries).
• Experience as a Field CRA monitor at least for 2-3 years (CROs or Pharma Industry)
• Excellent Knowledge of Good Clinical Practice (GCP), ICH regulations.
• Experience in preparing clinical study documentation for study set up, maintenance and closing.
• Experience in managing and developing relationships with Contract Research Organizations (CROs).
• Global study experience
• Life science or medical graduate or other relevant qualifications.