Project Manager (Romania)
Core
Ensure successful initiation, planning, execution, monitoring, controlling, and closure of clinical research projects while maintaining compliance with budget, scope, timelines, SOPs, GCP, and regulatory requirements. (via careerplan.io/jobs/15-003-AC-A69-project-manager-romania-at-indero)
Role type
Junior Project Manager (Clinical Research)
Builds
Clinical studies for biotech and pharmaceutical sponsors
Domain
Clinical Research / Dermatology & Rheumatology
Required skills
Clinical trial management, GCP/ICH standards knowledge, Microsoft Office, project planning, stakeholder coordination, site activation oversight, data compliance, risk management, corrective action planning
Preferred skills
French language, matrix environment management, therapeutic expertise
Technologies
Microsoft Office suite
Responsibilities
Coordinate tasks and deadlines between departments; oversee project coordinators and SSU 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/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; 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