Clinical Regional Project Lead

PSI CRO AG

. Oversee, manage, and coordinate activities of project teams in designated countries .

Posted 10/14/2026full-timeRemote • PeruSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Clinical Operations management, ensuring compliance with ICH-GCP regulations and effective project oversight. Proficient in coordinating project teams, managing timelines, and achieving study milestones in the Oncology domain.

Highest-signal resume keywords

Clinical Research ExperienceStudy Manager ExperienceOncology ExpertiseProject Management SkillsMS Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Operations ManagementProject PlanningKPI ManagementSite MonitoringRegulatory SubmissionsBudget NegotiationTraining DevelopmentData RetrievalPerformance Issue ResolutionStudy Audit Preparation

Soft Skills

Communication SkillsPresentation SkillsCustomer-Service SkillsTeam BuildingLeadership Skills

Tools & Technologies

MS ProjectTracking SystemsClinical Trial Management Systems

Industry Keywords

ICH-GCPLife SciencesOncologyGastrointestinal (GI)Clinical Trial Management

About the role

Key responsibilities & impact

Oversee, manage, and coordinate activities of project teams in designated countries
Ensure consistency of Clinical Operations processes across regions
Ensure study milestones are met at country and regional levels
Plan, implement, and manage 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
Collect and report project status updates internally and externally
Develop and update project planning documents, essential study documents, and project manuals/instructions
Manage and report Key Performance Indicators (KPIs)
Ensure project timelines and subject enrollment targets are met
Coordinate maintenance of study-specific and corporate tracking systems
Coordinate site contractual startup and budget negotiations
Establish communication lines and supervise clinical project team members’ performance
Identify, escalate, and resolve resourcing and performance issues
Conduct and supervise therapeutic area training
Prepare presentations and conduct Investigator training
Ensure compliance with the project-specific training matrix
Perform field training of Monitors
Supervise site selection, site initiation, routine monitoring, and closeout visits
Oversee investigator and site payments, CRF data retrieval/upload and 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/approve project-related expenses and timesheets when delegated

Requirements

What you’ll need

College/University degree in Life Sciences or an equivalent combination of education, training & experience is required
Prior experience in Clinical Research and on-site monitoring is required
Prior experience monitoring within the US
Experience as a Study Manager/Clinical Trial Manager with the ability to supervise project activities as a Regional Lead or equivalent is required
Experience in Oncology is required
Experience in GI is preferred
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

Benefits

Comp & perks

Remote work options
Career advancement opportunities
Opportunity to learn new things
Employee-focused company culture