Local Clinical Project Manager

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.

Your key responsibilities:

Overall responsibility for the study commitments within the country.
Lead and optimize the performance of the study team at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations.
Lead development of Local Monitoring Plan.
Perform any required co-monitoring & QC visits with study monitor(s)
Review of monitoring visit reports and pro-actively advice the Monitor(s) on study related matters.
Proactively identify and facilitate resolution of complex study problems and issues.
Contribute to patient recruitment strategy with monitors, including regular communication with concerned Investigators as necessary.
Coordinate the process for selection of potential Investigators.
Plan and lead national Investigator meetings, in line with local codes
Assist in forecasting study timelines, resources, recruitment, budget, study materials and drugs.
Ensure timely submission of proper application/documents to EC/IRB.
Work together with Regulatory Affairs to ensure timely delivery of proper application/documents for submissions to Regulatory Authority.