Global Clinical Study Manager – France

Excelya>All job opportunites>Full-time, Permanent Contract>Global Clinical Study Manager – France

Job description

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:

– Oversee and drive all aspects of the assigned global international clinical study(ies)outsourced to a CRO in respect of planning/timelines, quality, budget and defined goals

– Drive execution and report activities in conjunction with Clinical Development Program Directors

(CDPDs), Medical Dev. Directors (MDDs), and other team members

– Endorse project plan developed by the CRO in accordance with study objectives and

requirements in terms of team responsibility, risk mitigation plan, escalation process,

communication plan…

– Ensure the Global clinical studies are managed according to Good Clinical Practice (GCP), local

regulations, guidelines and SOPs in the required standard of quality

– Communicate and share the progress of the project, and work effectively as a Team

– Manage and lead the cross-functional Clinical Team and Contract Research Organization (CRO) in

collaboration with the CDPDs and team members responsible of the study

 

Minimum Requirements :

  • Intimate knowledge of regulatory requirement (ICH E6, GCP, EU Directive)
  • Good verbal and written communication skills (French, English) § Good computer literacy
  • Excellent organizational and management skills
  • Good leadership skills and capability to work within a team as leader and team player
  • Good understanding of the drug development process and knowledge of the pharmaceutical industry environment

The position is based in Paris Area with possibility of full remote

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