Clinical Trial Manager II – Remote (Serbia)
syneoshealth · SRB-Remote
Description du poste
About the role
Syneos Health is seeking an experienced Clinical Trial Manager II to lead and oversee Phase 1‑4 clinical research studies from a remote location in Serbia. You will coordinate site management, monitoring, and data integrity while ensuring compliance with GCP and regulatory standards.
Key responsibilities
- Provide strategic oversight of site management, clinical monitoring, and central monitoring deliverables with a focus on patient safety and data integrity.
- Track study progress against milestones, budgets, and regulatory requirements, escalating risks to the Project Manager as needed.
- Coordinate training, tool development, and system setup (CTMS, dashboards, EDC, eDiary, ePRO, TMF, IVRS/IWRS) for the study team.
- Collaborate with investigators, CROs, and functional leaders to meet activation, enrollment, and database lock targets.
Required profile
- Proven experience in clinical trial management across multiple phases (1‑4) and therapeutic areas.
- Strong understanding of GCP, regulatory compliance, and risk assessment methodologies.
- Ability to lead and supervise CRA and central monitor teams, managing resources and performance.
Required skills
- Clinical Trial Management System (CTMS) proficiency
- Electronic Data Capture (EDC) platforms
- eDiary and electronic Patient Reported Outcomes (ePRO) tools
- Trial Master File (TMF) management
- IVRS/IWRS systems
- Dashboard creation and data visualization
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