Excelya
Excelya
Excelya este o organizație globală de cercetare contractată (CRO) care ajută companiile de biotehnologie, farmaceutice și de dispozitive medicale să dezvolte și să furnizeze produse pentru sănătate. Activă în 28 de țări, compania oferă soluții complete, servicii funcționale (FSP) și soluții de asigurare a resurselor pentru o gamă largă de arii terapeutice. Abordarea sa colaborativă și flexibilă le oferă clienților expertiza și capacitatea de execuție necesare pentru a avansa terapii care schimbă vieți.

Senior Clinical Project Manager - Hybrid France

Lead local pharmaceutical clinical trial delivery for Excelya, a European contract research organization. Coordinate regulatory compliance, investigational sites, vendors, recruitment, data quality, and collaboration with global study teams.

Descriere

  • Manage local clinical trial activities from study start-up through close-out
  • Deliver global study plans locally while meeting timelines and quality expectations
  • Act as the primary contact for investigational sites and regional stakeholders
  • Maintain compliance with local regulations, ICH-GCP, and internal standard operating procedures
  • Coordinate submissions to competent authorities and ethics committees when needed
  • Track regulatory milestones and oversee corrective actions
  • Support site selection, activation, monitoring, and close-out with CRAs and vendors
  • Manage local vendor relationships across logistics, laboratory, and CRO services
  • Monitor recruitment, site performance, and operational metrics
  • Partner with global study teams and medical, regulatory, and clinical operations functions
  • Attend study meetings and report on local progress, issues, and outcomes
  • Assist with risk mitigation and operational problem-solving
  • Oversee data quality, query resolution, and documentation compliance
  • Monitor KPIs, recruitment, timelines, and operational deliverables
  • Support audit and inspection readiness activities

Cerințe

  • Background in clinical operations within a pharmaceutical company or CRO
  • Experience working as a Clinical Project Manager, Study Manager, or in a comparable role
  • Prior participation in interventional Phase II–IV trials is preferred
  • Strong knowledge of ICH-GCP, regulatory requirements, and local clinical research practices
  • Experience working with investigators, CROs, and cross-functional teams
  • Well-developed organizational, operational, and communication abilities
  • Able to prioritize and manage multiple responsibilities in a fast-moving setting
  • Fluent written and spoken French and English

Beneficii

  • Build expertise through varied and engaging projects
  • Work alongside recognized industry specialists
  • Help advance scientific, operational, and human knowledge
  • Join a workplace that recognizes individual strengths and supports initiative
  • Develop professionally while contributing to a shared mission
  • Be part of an organization focused on employee experience
  • Work with an ambitious healthcare company and a 900-person team

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