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 oversee Phase 1‑4 clinical studies remotely from Serbia. You will coordinate site management, monitoring, and data integrity while ensuring compliance with GCP and regulatory standards.
Key responsibilities
- Oversee site management, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol compliance and data integrity.
- Track study progress against milestones, budgets and client deliverables, escalating risks to the project manager as needed.
- Coordinate training, tool setup (CTMS, dashboards, EDC) and user acceptance testing for the study team.
- Collaborate with functional leaders (Study Start‑Up, Patient Recruitment, Data Management) to meet activation, enrollment and database lock targets.
Required profile
- Proven experience in clinical trial management across multiple phases, including site oversight and risk mitigation.
- Strong understanding of GCP, regulatory requirements and clinical monitoring strategies.
- Ability to supervise CRA and central monitor teams, allocate resources and ensure quality deliverables.
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.
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