Regional Project Lead

Job Description

The Regional Project Lead is a senior level clinical trial manager who oversees, manages, and coordinates activities of project teams in designated countries and ensures consistency of Clinical Operations processes across regions. They ensure meeting 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 (e.g., PSI QSDs or Sponsor QMS 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 (if delegated by the Project Manager)
• Collections 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
• Covers maintenance of study-specific and corporate tracking systems
• Covers coordination of 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
• Covers therapeutic area training of the project team (if delegated by the Project Manager)
• Covers preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits
• Covers supervision of investigator and site payments, as well as CRF data retrieval/ upload and monitoring and the query resolution process
• Covers supervision of project team preparation for study audits/ inspections and resolution of audit/ inspection findings
• Covers coordination of conduct of supervised monitoring visits
• Covers review of site visit reports and ensures monitoring and reporting standards are met
• Covers coordination of preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications
• Covers oversight of the safety information flow and participation in feasibility research
• Covers review/approval of project related expenses and timesheets (if delegated by the Project Manager)

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience is required
• Prior experience in Clinical Research and on-site monitoring is required
• Experience as a Study Manager/Clinical Trial Manager with the ability to supervise project activities as a Regional Lead or equivalent is required
• Experience in Oncology is required
• Experience in GI is preferred
• Full working proficiency in English
• Proficiency in MS Office applications, including MS Project
• Communication, presentation and customer-service skills
• Ability to negotiate and build relationships at all levels
• Team building, leadership and organizational skills

Additional Information

For this position PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.