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CTM II – Sponsor Dedicated (Remote – Argentina)

syneoshealth · ARG-Remote

Nuevo Remote
Remote 🇬🇧 English
CTMS EDC eDiary ePRO TMF IVRS/IWRS GCP ICH guidelines

Descripcion del puesto

About the role

Syneos Health is seeking an experienced CTM II professional to provide sponsor‑dedicated oversight of site management, clinical monitoring and central monitoring activities on a remote basis for studies conducted in Argentina. The role focuses on patient safety, protocol compliance and data integrity while collaborating with cross‑functional teams.

Key responsibilities

  • Oversee site interactions from activation through close‑out, including recruitment, investigator payments and issue resolution.
  • Identify and mitigate risks using the Risk Assessment and Categorization Tool (RACT) and monitor study budgets, timelines and quality.
  • Coordinate with Study Start‑Up, Patient Recruitment and Data Management to meet activation, enrollment and database lock targets.
  • Develop and maintain clinical study tools such as the Clinical Monitoring Plan and ensure CTMS, dashboards and other systems are configured and tested.
  • Provide training on protocol specifics, CRF completion, SOPs and monitoring strategies to the study team.
  • Review monitoring documentation, ensure compliance with GCP/ICH guidelines and support inspection readiness.

Required profile

  • Bachelor’s degree or RN in a related field, or equivalent experience.
  • Proven ability to lead and align multi‑disciplinary teams to achieve project milestones.
  • Experience working in an international, remote environment.
  • Strong understanding of site management, clinical and central monitoring processes.

Required skills

  • Clinical Trial Management System (CTMS) usage and configuration.
  • Electronic Data Capture (EDC) platforms.
  • eDiary and Electronic Patient Reported Outcomes (ePRO) systems.
  • Trial Master File (TMF) management.
  • IVRS/IWRS systems.
  • Risk‑based monitoring methodology.
  • Good Clinical Practice (GCP) and ICH guideline knowledge.

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Publicado hace 14 horas

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