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Clinical Trial Manager II – Remote (Romania/Hungary)

syneoshealth · ROU-Remote

New Remote
Remote 🇬🇧 English
CTMS EDC eDiary ePRO TMF IVRS/IWRS

Job description

About the role

Syneos Health is seeking an experienced Clinical Trial Manager II to lead Phase 1‑4 studies from a remote location in Romania or Hungary. You will coordinate site activities, ensure regulatory compliance, and drive study milestones while collaborating with investigators, sponsors, and internal functional teams.

Key responsibilities

  • Oversee site management, clinical monitoring and central monitoring deliverables with focus on patient safety, protocol/GCP compliance and data integrity.
  • Track study progress against milestones, budget and client deliverables, escalating risks to the Project Manager.
  • Coordinate site activation, patient recruitment, investigator payments and site close‑out activities.
  • Develop and maintain clinical study tools, templates and monitoring plans; ensure CTMS, dashboards and other systems are operational.
  • Provide training to study teams on protocol specifics, CRF completion, SOPs and data management timelines.

Required profile

  • Proven experience in clinical trial management, preferably overseeing both site and central monitoring functions.
  • Strong understanding of GCP, regulatory requirements and risk mitigation strategies.
  • Ability to supervise CRA and central monitor teams, allocate resources and manage performance.

Required skills

  • Clinical Trial Management System (CTMS)
  • Electronic Data Capture (EDC)
  • eDiary and electronic Patient Reported Outcomes (ePRO) platforms
  • Trial Master File (TMF) management
  • IVRS/IWRS systems
  • Risk Assessment and Categorisation Tool (RACT)

Questions fréquentes

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Source : ats:workday

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Published 2 ore în urmă

Expires peste 1 lună

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syneoshealth

ROU-Remote