Job Description

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
• 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)

Qualifications

• 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.

Additional Information

Why Join PSI?

At PSI, you'll join a privately owned, global CRO with over 30 years of steady growth. Unlike many organizations in our industry, we've remained independent, have never experienced layoffs, and continue to invest in our people.

Here you'll find:

• Opportunities to lead complex global studies
• A collaborative, people-first culture
• Career growth and professional development
• Flexible working arrangements
• A stable organization where long-term careers are built
• Meaningful work that helps bring innovative therapies to patients around the world