Project Manager (USA)
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.
Role type
Junior Project Manager (Clinical Research)
Builds
Clinical studies for biotech and pharmaceutical sponsors
Domain
Clinical Research / Pharmaceutical / Biotechnology
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, resource-based project planning, people management in matrix environments
Preferred skills
French language, experience managing small to medium projects, therapeutic expertise
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 Project Manager II; manage stakeholder needs and expectations; ensure team training; plan activities and resources; manage quality of work and 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; 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