Global Clinical Trial Assistant F/H

il y a 3 jours

BoulogneBillancourt, France Excelya Temps plein

I. Excelya

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.

II Main responsibilities :

  • To assist in the delivery of Clinical Development objectives and achieve Clinical Excellence, by taking responsibility on the TMF management, Budget tracking...
  • To also perform and/or coordinate some specific study activities and assist the Global Clinical Project Manager (GCPM) and Program Director on request
  • Support the clinical project management and monitoring of clinical studies, including liaison with, monitors, CROs, drug vendors, central laboratories and other vendors for study related tasks.
  • Be an active member of the study team and take responsibilities for service provider oversight for his/her scope of responsibility according to procedures
  • Be responsible for monitoring, verifying and archiving the Trial Master File as per SOPs, instructions and trainings. This includes review and QC check of the TMF to ensure quality and completeness in view of audit, inspection and archiving.
  • Be responsible for follow up and review of financial documents, in collaboration with GCPM.
  • Responsible for data entry and status updates within the Clinical Trial Management System Data Entry: CTMS using a Clinical Manager technical role for the assigned studies, with support of GCPM or Clinical Monitoring lead (CML) as needed.

III. Qualifications :

  • At least 3 years of work experience and training in clinical operations in a similar role.
  • Substantial administrative experience or qualified to degree level.
  • Fluent in English /Strong intermediate level Proficiency
  • Knowledge of regulatory documents or medical terminology is recommended.
  • Experience of working with multidisciplinary groups and ability to work within a team environment.
  • Experience of managing and developing relationships with international Service Providers (SPs).
  • Experience of tracking and manipulating clinical study documents and provider invoices.
  • Strong organizational and skills
  • Excellent verbal and written communication skills.
  • Advanced knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader, MS Teams, OneDrive…)
  • Basic Financial and Pharmaceutical Industry R&D knowledge

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