Regional Project Lead — Global Trials & Growth

Psi CRO; Oregon; Hybrid; USD 110,000 - 140,000; Full time

Job summary

PSI CRO is seeking a Regional Project Lead in the United States to drive delivery of multicountry clinical trials, collaborating with Project Managers, CRAs, sponsors, and cross-functional teams. You will mentor project teams and uphold the highest standards of quality and regulatory compliance.

You’ll coordinate timelines, budgets, site activities, and communications across designated regions, ensuring efficient execution and continual process improvements.

Qualifications

• College/University degree in Life Sciences or equivalent
• Prior experience in Clinical Research and independent on-site monitoring is required
• Experience as a Study Manager/Clinical Trial Manager with supervisory responsibilities as Regional Lead or equivalent
• Therapeutic expertise in Oncology and/or Gastroenterology required
• Full working proficiency in English
• Proficiency in MS Office applications, including MS Project
• Strong communication, presentation and customer-service skills
• Ability to negotiate and build relationships at all levels; team building, leadership and organizational skills

Responsibilities

• 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 (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 KPIs for designated countries and clinical project team members
• Ensures 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 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)

Skills

Clinical Research experience

On-site monitoring experience

CTM/Study Manager

Oncology

Gastroenterology

English proficiency

Communication

Presentation skills

Customer service

Negotiation

Relationship building

Leadership

Organization

Education

Life Sciences degree

Tools

MS Office

MS Project

Job description

PSI CRO is seeking a Regional Project Lead in the United States to drive delivery of multicountry clinical trials, collaborating with Project Managers, CRAs, sponsors, and cross-functional teams. You will mentor project teams and uphold the highest standards of quality and regulatory compliance.

You’ll coordinate timelines, budgets, site activities, and communications across designated regions, ensuring efficient execution and continual process improvements.