Regional Project Lead

PSI CRO AG

Regional Project Lead guiding multi-country clinical trials for PSI CRO, a global contract research organization. Supervising project teams, sites, regulatory activities, monitoring, timelines, and enrollment.

Posted 8/5/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical research projects, ensuring compliance with industry regulations and effective communication across project teams. Proficient in project planning, KPI management, and therapeutic-area training, particularly in Oncology and Gastroenterology.

Highest-signal resume keywords

Clinical Research ManagementOncology ExpertiseKPI ManagementMS Office ProficiencyProject Planning

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchIndependent On-Site MonitoringStudy ManagementProject ManagementRegulatory SubmissionsBudget NegotiationData RetrievalMonitoring StandardsTraining DevelopmentPerformance Supervision

Soft Skills

Communication SkillsPresentation SkillsCustomer-Service SkillsTeam-Building SkillsLeadership Skills

Tools & Technologies

MS OfficeMS Project

Industry Keywords

ICH-GCPClinical TrialTherapeutic-Area TrainingSite SelectionSite InitiationMonitoring VisitsInvestigator TrainingSafety Information FlowFeasibility ResearchControlled Documents

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Plan, implement, and manage clinical research projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents
Act as primary or secondary project management contact for project teams and PSI support services in designated countries
Review study status and report progress when delegated by the Project Manager
Collect and report project status updates for designated regions internally and externally
Develop and update project planning documents, essential study documents, and project manuals/instructions
Manage and report KPIs for designated countries and clinical project team members
Ensure project timelines and subject enrollment targets are met in designated countries
Coordinate study-specific and corporate tracking systems
Coordinate site contractual startup and budget negotiations
Establish project-team communication lines and supervise clinical project team members’ performance
Identify, escalate, and resolve resourcing and performance issues
Conduct or supervise therapeutic-area training of project teams when delegated
Prepare presentations and conduct Investigator training
Ensure team compliance with project-specific training matrices
Conduct field training of Monitors tailored to project needs
Supervise site selection, site initiation, routine monitoring, and closeout visits
Oversee investigator and site payments, CRF data retrieval/upload, monitoring, and query resolution
Supervise project-team preparation for study audits/inspections and resolution of findings
Coordinate supervised monitoring visits
Review site visit reports and ensure monitoring and reporting standards are met
Coordinate initial and follow-up Regulatory and Ethics Committee submissions and notifications
Oversee safety information flow and participate in feasibility research
Review and approve project-related expenses and timesheets when delegated by the Project Manager

Requirements

What you’ll need

College/University degree in Life Sciences or equivalent combination of education, training, and experience required
Prior experience in Clinical Research and independent on-site monitoring required
Experience as a Study Manager/Clinical Trial Manager with ability to supervise project activities as a Regional Lead or equivalent 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
Must not require a work visa for employment or continued employment now or anytime in the future

Benefits

Comp & perks

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