Clinical Regional Project Lead

PSI CRO AG

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

Posted 10/14/2026full-timeRemote • ChileSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Operations management, ensuring compliance with ICH-GCP and industry regulations while effectively coordinating project teams across regions. Proficient in project planning, monitoring, and reporting, with a strong focus on achieving study milestones and managing key performance indicators.

Highest-signal resume keywords

Clinical Research ExperienceStudy Manager ExperienceOncology ExpertiseMS Office ProficiencyTeam Leadership Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Project ManagementClinical Trial ManagementOn-Site MonitoringRegulatory SubmissionsBudget NegotiationKPI ManagementStudy Document DevelopmentData RetrievalTraining SupervisionFeasibility Research

Soft Skills

Communication SkillsPresentation SkillsCustomer-Service SkillsNegotiation SkillsTeam Building Skills

Tools & Technologies

MS ProjectClinical Tracking Systems

Industry Keywords

ICH-GCPLife SciencesOncologyGastrointestinal (GI)Clinical Operations

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 by the project team at country and regional level
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
Perform study status reviews and progress reporting 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 Key Performance Indicators for designated countries and clinical project team members
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 within the project team and supervise clinical project team members’ performance
Identify, escalate, and resolve resourcing and performance issues
Conduct and supervise therapeutic area training of the project team when delegated
Prepare presentations and conduct Investigator training
Ensure team compliance with the project-specific training matrix
Perform field training of Monitors tailored to project needs
Supervise preparation, conduct, and reporting of 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/approve project-related expenses and timesheets when delegated by the Project Manager

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

Employees can work remotely
Advance your career in clinical research
Learning new things while growing with a rapidly growing company that puts its people first