Full-Time Regional Project Lead

• Manages and coordinates activities of project teams in designated countries and ensures consistency of Clinical Operations processes across regions.
• Ensures study milestones are met by the project team on a country and regional level.
• Ensures planning, implementation, and management of projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents.
• Acts as primary or secondary project management contact for the project team and PSI support services in designated countries.
• Performs study status review and progress reporting.
• Collects and reports project status updates for designated regions, both internally and externally.
• Develops and updates project planning documents, essential study documents and project manuals/ instructions.
• Manages and reports on Key Performance Indicators (KPIs) for designated countries and clinical project team members.
• Ensures that the project timelines and subject enrollment targets are met in designated countries.
• Coordinates maintenance of study-specific and corporate tracking systems.
• Coordinates site contractual startup and budget negotiations.
• Establishes communication lines within the project team and supervises clinical project team members’ performance.
• Identifies, escalates and resolves resourcing and performance issues.
• Conducts and supervises therapeutic area training of the project team.
• Prepares presentations and conducts training of Investigators.
• Ensures team compliance with project-specific training matrix.
• Performs field training of Monitors tailored to the project needs.
• Supervises preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits.
• Oversees investigator and site payments, as well as CRF data retrieval/ upload and monitoring and the query resolution process.
• Supervises project team preparation for study audits/ inspections and resolution of audit/ inspection findings.
• Coordinates conduct of supervised monitoring visits.
• Reviews site visit reports and ensures monitoring and reporting standards are met.
• Coordinates preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications.
• Oversees the safety information flow and participates in feasibility research.
• Reviews/ approves project related expenses and timesheets.

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