CTM II – Sponsor Dedicated (Remote – Argentina)
syneoshealth · ARG-Remote
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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