Regional Project Lead

At PSI CRO, our Regional Project Leads are trusted leaders who drive the successful delivery of clinical trials across multiple countries. You'll partner with Project Managers, CRAs, sponsors, and cross-functional teams to ensure studies are executed efficiently while mentoring project teams and maintaining the highest standards of quality.
If you're an experienced Clinical Trial Manager or Regional Lead looking for a collaborative environment where your expertise is valued and your career can continue to grow, we'd love to hear from you.
Job Duties Include:
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 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 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 Research and independent 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
Therapeutic expertise in Oncology and/or Gastroenterology required
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
For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

Employment type
Full-time

Work arrangement
Yes