Regional Project Lead

PSI CRO AG

. Ensure planning, implementation, and management of projects comply with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents .

Posted 10/23/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Research project management, ensuring compliance with ICH-GCP regulations and effective communication across project teams. Proficient in managing project timelines, budgets, and performance indicators while providing leadership and training in therapeutic areas such as Oncology and Gastroenterology.

Highest-signal resume keywords

Clinical Research ExperienceStudy Manager/Clinical Trial ManagerOncology/Gastroenterology ExpertiseMS Office ProficiencyProject Management Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Project ManagementClinical Trial ManagementRegulatory SubmissionsKey Performance Indicators ManagementSite MonitoringBudget NegotiationTraining SupervisionData Retrieval/UploadStudy Audit PreparationTherapeutic-Area Training

Soft Skills

Communication SkillsPresentation SkillsCustomer-Service SkillsTeam BuildingLeadership Skills

Tools & Technologies

MS ProjectTracking SystemsStudy ManualsEssential Study DocumentsProject Planning Documents

Industry Keywords

ICH-GCPClinical ResearchStudy Status ReportingSite SelectionInvestigator TrainingSafety Information FlowFeasibility ResearchControlled DocumentsPerformance Issues ResolutionContractual Startup

About the role

Key responsibilities & impact

Ensure planning, implementation, and management of projects comply 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 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 project-team communication lines and supervise clinical project team performance
Identify, escalate, and resolve resourcing and performance issues
Conduct or supervise therapeutic-area training for project teams
Prepare presentations and conduct Investigator training
Ensure compliance with project-specific training matrices
Conduct field training of Monitors
Supervise site selection, site initiation, routine monitoring, and closeout visits
Oversee investigator and site payments, CRF data retrieval/upload, monitoring, and query resolution
Supervise 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

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 independent on-site monitoring is required
Experience as a Study Manager/Clinical Trial Manager with the ability to supervise project activities as a Regional Lead or equivalent is 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