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Regional Project Lead
PSI CRO AGRegional Project Lead coordinating North American clinical trials for PSI, a global contract research organization. Overseeing project teams, study milestones, sites, training, payments, and audits.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical project management, including site monitoring, team leadership, and compliance with regulatory standards. Proficient in developing project documentation and ensuring project timelines and enrollment targets are achieved.
Highest-signal resume keywords
Clinical Project ManagementSite Monitoring ExperienceLead Monitor ExperienceOncology ExperienceMS Office Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project PlanningStudy Document DevelopmentSite SelectionContractual NegotiationsBudget NegotiationsCompliance ManagementTraining SupervisionMonitoring StandardsAudit PreparationProgress Reporting
Soft Skills
Communication SkillsPresentation SkillsCustomer-Service SkillsTeam-Building SkillsLeadership SkillsOrganizational Skills
Tools & Technologies
MS ProjectTracking Systems
Certifications & Qualifications
MPharmRN
Industry Keywords
Clinical OperationsOncologyGastroenterologyInfectious DiseasesAutoimmune DiseasesRare Disease Indications
About the role
Key responsibilities & impact- Streamline project team activities and ensure consistency of Clinical Operations processes across North America
- Act as project management contact for project teams and PSI support services
- Review study status and report progress to clients and global stakeholders
- Collect and report project status updates
- Develop and update project planning documents, essential study documents, and project manuals/instructions
- Ensure project timelines and subject enrollment targets are met
- Coordinate maintenance of study-specific and corporate tracking systems
- Oversee site selection and startup, contractual negotiations, and budget negotiations
- Supervise project team and site training, including field training of monitors
- Ensure compliance with project-specific training matrices
- Supervise site selection, site initiation, routine monitoring, and closeout visits
- Review site visit reports and ensure monitoring and reporting standards are met
- Oversee investigator and site payments
- Supervise preparation for study audits/inspections and resolution of findings
- Participate in regional project oversight for North America
Requirements
What you’ll need- MPharm, RN, or university/college degree in Life Sciences, or equivalent combination of education, training, and experience
- Minimum 4 years' site monitoring experience
- At least 2 years' experience as Lead Monitor
- Experience supervising clinical project activities and leading clinical project teams
- Experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or rare disease indications preferable
- Communication, presentation, and customer-service skills
- Team-building, leadership, and organizational skills
- Full working proficiency in English
- Proficiency in MS Office applications, including MS Project
- Must not require work visa sponsorship for employment now or in the future
Benefits
Comp & perks- Stable and secure workplace
- Inclusive culture where colleagues feel welcomed and valued
- Professional development and career success investment