Project Data Manager

Excelya

  • Paris
  • CDI
  • Temps-plein
  • Il y a 15 jours
  • Postuler facilement
Why Join Us?At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects, working alongside industry experts to enhance scientific knowledge and improve the patient journey.About the JobWe are seeking an Project Data Manager to strengthen our commitment to delivering high-quality products. In this pivotal role, you will lead quality assurance processes, ensure regulatory compliance, and drive continuous improvement initiatives.Main Activities:
  • Deeply acknowledges and strictly follows Client’s and Excelya SOPs, guidelines and appropriate local and international legislation.
  • Acts as Functional Lead for Data Management including primary DM contact for Sponsors and for internal liaison between Data Management and Project Management, Clinical Monitoring, and other functional groups.
  • Coordinate the work of the assigned Data Management team.
  • Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard
  • Operating Procedures (SOPs), guidelines, and regulations.
  • Responsible for financial management of assigned projects, including revenue recognition, changes in scope, including liaison with Finance and Contracts groups as needed.
  • Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management.
  • Plan, manages, and requests resources for assigned projects.
  • Develop and maintain project plans, specifications and documentation in line with SOP requirements.
  • Maintains documentation on an ongoing basis and ensures that all TMF filing is complete and up to date.
RequirementsAbout YouWe are looking for candidates who embody our values of Audacity, Care, and Energy:
  • Bachelor’s degree qualification in a Scientific discipline is preferred
  • Five or more years as a Data Manager and 4 years acting as a Lead Data Manager or equivalent combination of education, training, and experience
  • Knowledge and understanding of ICH GCP and other relevant ICH, EU or FDA guidelines to maintain regula-tory compliance · Understanding of recommended CDM best practices and associated documentation
  • Fluent in local language and English (written and spo-ken)
  • Ability to travel as necessary (up to 25%)
BenefitsBenefitsWhy Join Us?At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.Here's what makes us unique—We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

Excelya