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SUSUSONITY

Clinical Site Management Excellence Lead(m/w/x)

Eysins
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung

Global harmonization of clinical trial monitoring and site management, integrating digital health technologies. 12+ years of clinical research experience required. Preparing for and responding to regulatory inspections, adapting to decentralized and risk-based monitoring.

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Anforderungen

  • Advanced degree in Life Sciences, Medicine, Clinical Research, or related field, or equivalent professional experience
  • 12+ years of experience in clinical research, with deep expertise in site management and clinical monitoring across global environments
  • Proven track record of owning end-to-end clinical processes, including process design, documentation, performance oversight, and continuous improvement in a regulated setting
  • Highly knowledgeable in ICH-GCP guidelines, including ICH E6(R3), and experienced in applying Quality by Design and risk-based quality management principles
  • Led cross-functional initiatives in complex matrix organizations, building alignment across diverse teams, CROs, and vendors without direct authority
  • Partnered with technology and digital teams to shape system requirements and drive adoption of tools that support process compliance and operational efficiency
  • Strong analytical and data-driven approach to translate performance metrics into targeted process improvements
  • Comfortable in a global, multicultural setting and willing to travel internationally up to 20% of the time

Aufgaben

  • Drive excellence in clinical trial monitoring and site management
  • Ensure global harmonization of clinical monitoring practices
  • Prepare for and respond to regulatory inspections
  • Adapt to evolving trial models, including decentralized and risk-based monitoring
  • Integrate digital health technologies into site management
  • Define and implement clinical monitoring strategies
  • Coordinate site activation, initiation, monitoring, and close-out
  • Manage ongoing site oversight, escalation, and issue resolution
  • Link site management activities to CAPA processes
  • Ensure clear communication and role clarity across functions
  • Align site-facing engagement with GDO and R&D peers
  • Collaborate with Regional and Cluster Heads on process implementation
  • Partner with study teams, CROs, and vendors for effective site management
  • Shape and implement GCP-compliant clinical monitoring processes
  • Align processes with regulatory expectations and organizational goals
  • Support modern clinical trial delivery needs

Berufserfahrung

12 Jahre

Ausbildung

Master-Abschluss

Sprachen

Englischverhandlungssicher

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Über das Unternehmen

SU
HealthcareEysins

Das Unternehmen entwickelt Medikamente, intelligente Geräte und innovative Technologien in Therapiegebieten wie der Onkologie, Neurologie und Fruchtbarkeit.

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