Clinical Regional Project Lead

PSI CRO AG

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

Posted 10/14/2026full-timeRemote • ColombiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Operations management, ensuring compliance with ICH-GCP regulations and effective project oversight across regions. Proficient in coordinating project teams, managing timelines, and delivering training while maintaining high standards of communication and performance.

Highest-signal resume keywords

Clinical Research ExperienceStudy Manager ExperienceOncology ExpertiseMS Office ProficiencyProject Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Operations ManagementProject PlanningRegulatory ComplianceKey Performance Indicator ManagementSite MonitoringBudget NegotiationTraining DevelopmentData RetrievalFeasibility ResearchStudy Audit Preparation

Soft Skills

Communication SkillsPresentation SkillsCustomer-Service SkillsTeam BuildingLeadership Skills

Tools & Technologies

MS ProjectClinical Trial Management SystemsTracking SystemsStudy ManualsEssential Study Documents

Industry Keywords

ICH-GCPClinical TrialsOncologyGastrointestinalLife Sciences

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 project teams 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 provide 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 study-specific and corporate tracking systems
Coordinate site contractual startup and budget negotiations
Establish communication lines within project teams and supervise clinical project team members' performance
Identify, escalate, and resolve resourcing and performance issues
Conduct and supervise therapeutic area training of project teams when delegated
Prepare presentations and conduct Investigator training
Ensure compliance with project-specific training matrices
Provide field training to 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 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 option
Career growth opportunities
Opportunities to coordinate a variety of tasks and learn new things
Opportunity to grow with a rapidly growing company that puts its people first