Local Clinical Trial Manager - FSP, Poland
Core
Leads local clinical study teams and manages end-to-end delivery of clinical trials within Poland, ensuring adherence to time, budget, and quality expectations while coordinating with central teams and local stakeholders.
Role type
Local Clinical Trial Manager (FSP)
Builds
Clinical studies for pharmaceutical/biotech clients
Domain
Clinical Research / Life Sciences
Required skills
Project management, team leadership, budget management, vendor management, regulatory compliance (GCP/ICH), risk management, site selection, contract negotiation, data accuracy review, safety reporting
Preferred skills
Knowledge of local healthcare systems, disease area pathology, translation coordination, audit/inspection handling
Technologies
Trial master file systems, monitoring tracking tools, study databases
Responsibilities
Lead local study teams and manage cross-functional experts; Serve as operational point of contact between central and local teams; Ensure within-country delivery meets time, budget, and quality expectations; Develop and maintain country study plans and risk assessments; Review and approve monitoring visit reports; Manage study budgets and local vendor contracts; Prepare local regulatory submissions and informed consent forms; Coordinate training and communication with clinical sites.
Seniority
Mid-level, hands-on IC
