Project Manager (Poland)
Core
Ensure successful initiation, planning, execution, monitoring, controlling, and closure of clinical research projects while maintaining compliance with budgets, scope, timelines, SOPs, GCP, and regulatory requirements.
Role type
Junior Project Manager (Clinical Research)
Builds
Clinical studies for pharmaceutical, biotechnology, and CRO clients
Domain
Clinical Research / Pharmaceutical / Biotechnology
Required skills
Clinical trial management, GCP and ICH standards knowledge, FDA and Canadian regulations knowledge, Microsoft Office suite, project planning, resource management, site selection and qualification, patient recruitment monitoring, data management compliance, change control and risk management, stakeholder communication (via careerplan.io/jobs/15-003-AC-A66-project-manager-poland)
Preferred skills
French language proficiency, experience in dermatology or rheumatology, matrix environment management
Technologies
Microsoft Office suite
Responsibilities
Coordinate tasks and deadlines between departments; oversee project coordinators and team members; interact with vendor management for site activation; assist in managing sponsor expectations; plan activities and resources; manage quality of deliverables; reconcile study trackers; analyze discrepancies and implement corrective actions; enforce change control and risk management; review and draft project operational plans; ensure study documents meet country requirements; oversee site selection and qualification; monitor patient recruitment; participate in Investigator's Meetings; oversee regulatory submissions; ensure collection of essential site documents; assist with TMF quality reviews and audits; support clinical monitoring activities; track site visits and compliance; maintain training matrix; support sites with study materials; ensure CRF compliance and query resolution.
Seniority
Junior, hands-on IC