Clinical Trial Manager II – Remote (Romania/Hungary)
syneoshealth · ROU-Remote
Job description
About the role
Syneos Health is seeking an experienced Clinical Trial Manager II to lead Phase 1‑4 studies remotely from Romania or Hungary. You will oversee site management, clinical monitoring and central monitoring activities, ensuring patient safety, protocol compliance and data integrity.
Key responsibilities
- Manage site interactions from activation through close‑out, including patient recruitment and investigator payments.
- Track study progress against milestones, budgets and regulatory requirements.
- Identify and mitigate risks using the Risk Assessment and Categorization Tool (RACT) and escalate issues to the Project Manager.
- Coordinate with functional leaders (Study Start‑Up, Patient Recruitment, Data Management) to meet activation, enrollment and database lock targets.
- Develop and maintain clinical study tools, monitoring plans and ensure CTMS, dashboards and other systems are operational.
Required profile
- Proven experience in clinical trial management, overseeing CRAs and central monitors.
- Strong understanding of GCP, protocol compliance and regulatory standards across regions.
- Ability to lead cross‑functional teams, prioritize tasks and communicate effectively with investigators and sponsors.
Required skills
- Clinical Trial Management System (CTMS) usage
- Electronic Data Capture (EDC) platforms
- eDiary and ePRO systems
- Trial Master File (TMF) management
- IVRS/IWRS systems
- Central monitoring dashboards
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Published 9 ore în urmă
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syneoshealth
ROU-Remote
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