Regional Project Lead

About PSI CRO

We are a dynamic global company, established in 1995, comprising over 2,800 passionate professionals dedicated to advancing medical science and delivering new medicines to patients in need. At PSI, we prioritize our people — staff, clients, and partners alike — and emphasize quality in all our work.

Position Overview

The Regional Project Lead is a senior clinical trial manager responsible for leading and coordinating project teams across several countries. This role ensures uniformity in Clinical Operations procedures regionally and guarantees that study milestones and objectives are met timely on both country and regional scales.

Key Responsibilities

• Plan, implement, and oversee clinical projects in compliance with industry standards, ICH-GCP guidelines, essential study documentation, and internal quality systems.
• Serve as the primary or secondary point of contact for project teams and support services within designated countries.
• Conduct study progress reviews and provide status reports when delegated by the Project Manager.
• Gather and relay project updates regionally to internal and external stakeholders.
• Maintain and update project planning documents, manuals, and essential study records.
• Manage and report on Key Performance Indicators for countries and team members under supervision.
• Ensure adherence to project timelines and subject recruitment goals across regions.
• Coordinate the upkeep of study-specific and corporate tracking tools.
• Handle site contractual startups and budget negotiations collaboratively.
• Establish communication frameworks within the project team and supervise performance of clinical team members.
• Identify, escalate, and resolve resource and performance challenges.
• Lead therapeutic area training for project teams when delegated.
• Prepare and deliver training sessions and presentations for investigators.
• Ensure compliance with project training requirements.
• Conduct monitor training tailored to project necessities.
• Supervise site selection, initiation, routine monitoring, and closeout processes.
• Oversee investigator/site payments, data collection and management, monitoring, and query resolutions.
• Prepare for and support study audits or inspections and manage the resolution of findings.
• Coordinate supervised monitoring visits and verify report quality and compliance.
• Manage regulatory and ethics committee submissions and notifications.
• Oversee safety data management and assist with feasibility research.
• Approve project-related expenses and timesheets if delegated.

Qualifications

• A degree in Life Sciences or equivalent education and experience.
• Previous clinical research and on-site monitoring experience.
• Proven background as a Study Manager or Clinical Trial Manager with supervision capabilities at a regional level.
• Oncology experience is mandatory; gastrointestinal experience is advantageous.
• Fluent in English with excellent communication and presentation skills.
• Proficiency in MS Office tools, including MS Project.
• Strong negotiation, relationship-building, leadership, team building, and organizational skills.
• Candidates must not require work visa sponsorship now or in the future.

Additional Information

This position offers the opportunity to significantly advance your career in clinical research by managing comprehensive full-service projects regionally and locally within an employee-focused and rapidly growing company. You will be actively involved in various study aspects, gaining broad experience.

Note: Employment is only open to individuals not requiring work visa sponsorship currently or at any point in the future.