Project Manager (Romania)
Core
Ensures successful initiation, planning, execution, monitoring, controlling, and closure of clinical research projects while ensuring compliance with budget, scope, timelines, SOPs, GCP, and regulatory requirements. (via careerplan.io/jobs/15-003-AC-A69-project-manager-romania)
Role type
Junior Project Manager (Clinical Research)
Builds
Clinical trial studies for pharmaceutical and biotechnology sponsors
Domain
Clinical Research / Clinical Trials
Required skills
Project management, GCP and ICH standards knowledge, FDA and Canadian regulations knowledge, Microsoft Office suite, oral and written English, problem-solving, organizational skills, people management, resource planning, change control, risk management, site selection and qualification, patient recruitment monitoring, data management compliance, training coordination
Preferred skills
French language, experience in dermatology or rheumatology, matrix environment management
Technologies
Microsoft Office suite
Responsibilities
Serve as primary contact for Sponsor, vendors, and internal team; coordinate tasks and deadlines between departments; oversee project coordinators and team members; interact with vendor management for site activation; escalate risks to senior PMs; manage stakeholder expectations; plan activities and resources; manage quality of deliverables; provide project status updates; reconcile study trackers; analyze discrepancies and implement corrective actions; enforce change control and risk management; draft project operational plans; ensure study documents meet country requirements; oversee site selection and qualification; monitor patient recruitment and subject status; 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