About PSI

PSI is a leading Contract Research Organization with more than 30 years in the industry offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

About This Role: Regional Project Lead

The Regional Project Lead is a senior-level clinical trial manager who oversees, manages, and coordinates the activities of project teams in designated countries, ensuring consistency of Clinical Operations processes across regions. They ensure study milestones are met by the project team at a country and regional level.

Key Responsibilities:

• 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 the 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).
• 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 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 (if delegated by the Project Manager).
• Prepares presentations and conducts training of Investigators.
• Ensures team compliance with the 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 the 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 (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:

Advance your career in clinical research and lead challenging full-service projects on the country/regional level while growing with a rapid company that puts its people first! You will get hands-on involvement in every aspect of the study.

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