Regional Project Lead

We are the company that cares — for our staff, our clients, our partners, and the quality of the work we do.

Founded in 1995, PSI CRO is a privately owned, global contract research organization with more than 3,000 passionate professionals dedicated to advancing medical science and improving patients' lives.

In an industry where change is constant, PSI stands apart. We have remained privately held, have never experienced a merger or acquisition, and have never had company-wide layoffs. Our long-term stability allows us to focus on what matters most - our people, our clients, and delivering exceptional clinical research.

If you're looking for a company where you can build a long-term career, grow professionally, and make a meaningful impact, PSI is the right choice for you.

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