Clinical Regional Project Lead

Psi CRO; Región Metropolitana de Santiago; On-site; CLP 58,939,000 - 78,585,000; Full time

Job summary

PSI is a leading Contract Research Organization with over 30 years in the industry, delivering quality services globally. The Regional Project Lead is a senior clinical trial manager who oversees project teams in designated countries and ensures consistency of Clinical Operations processes across regions.

They ensure study milestones are met, manage planning, KPIs, site initiation, budgets, and training of investigators, while maintaining regulatory compliance and effective communication with

Qualifications

• College/university degree in Life Sciences or equivalent required.
• Prior clinical research and on-site monitoring experience required.
• Experience monitoring within the US is required.

Responsibilities

• Oversee and coordinate regional project teams to ensure study milestones.
• Manage project planning, documentation, and regulatory submissions.
• Monitor budgets, KPIs, and site performance across designated countries.
• Coordinate site startup, monitoring visits, and closeout activities.
• Lead training of investigators and site staff as needed.

Skills

Communication skills

Presentation skills

Customer-service skills

Team leadership

Organizational skills

Education

Bachelor's degree in Life Sciences

Tools

MS Office

MS Project

Job description

PSI is a leading Contract Research Organization with more 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.

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)
• 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 teamand 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 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 (if delegated by the Project Manager)

• College/University degree in Life Sciences or an equivalent combination of education, training & experience is required
• Prior experience in Clinical Researchand on-site monitoring is required
• Prior experience monitoring within the US
• Experience as a Study Manager/Clinical Trial Managerwith theability 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

Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company that puts its people first.