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 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)
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syneoshealth
ROU-Remote
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