Clinical Observational Project Manager

Excelya>Full-time>Clinical Observational Project Manager

Job description

Excelya

Founded in 2014, Excelya is a “people centered” contract research organization (CRO).

We offer a personal and authentic experience within an ambitious young healthcare company on its way to becoming the leader in clinical research in Europe with our 800 Excelyates. Our unique one-stop provider service model – leveraging a full-service, functional service provider and consultancy – allows our Excelyates to evolve across a wide range of projects. Working with leading experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means enjoying a challenging professional environment that encourages personal, intellectual and operational participation so that together we can be the best in our field. We are committed to empowering each Excelyate to express their natural talents, develop their full potential and invest in our unique project.

 

Mission

Within the Medical Corporate & Patient Relations Department of one of our leading partners, we are recruiting a clinical project manager to manage our real life studies portfolio. He/she will be responsible for :

  • Contribute to the preparation of study documents and protocol amendments
  • Contribute to the CRO and supplier selection process
  • Supervise activities related to study feasibility and site identification in collaboration with the CRO and study team.
  • Oversee the site qualification and selection process and develop mitigation plans in collaboration with the CRO.
  • Monitor operational performance metrics (KPIs), milestones and budget for real life studies.
  • Identify problems and propose solutions.
  • Ensure the timelines and quality of document deliverables generated by the CRO are met.
  • Coordinate with the CRO in the preparation and execution of meetings, including kick off meeting, study team meetings, investigator meetings, data review meetings
  • Verify and validate reports generated by the CRO, such as monitoring visit reports and protocol deviation reports.
  • Ensure that the study FMR is complete and up to date.
  • Ensure and supervise study closure activities by the CRO.
  • Based in Ile de France.

Profile

  • Scientific background (Bac+5 or PhD)
  • Skills in CRO management
  • Significant knowledge in the management of real life studies and their regulatory environment at the European level
  • Good command of professional English
  • Excellent communication skills
  • Ability to make decisions

Summary

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