PSI CRO
Clinical Research
RegionalProjectLead
Neural analysis suggests this role is
optimal for mid candidates.
“Regional Project Lead at PSI CRO. Skills: Clinical trial management, Project management, Operations management, Cross-functional coordination. Oversee project teams. Manage project teams”
What You'll Achieve.
Ensure meeting study milestones; Ensure project timelines are met; Ensure subject enrollment targets are met
Industry & Context.
Issue resolution
What They're Looking For.
Must Have
College/University degree in Life Sciences, Prior experience in Clinical Research, Prior on-site monitoring experience, Experience as Study Manager/Clinical Trial Manager, Ability to supervise project activities as Regional Lead, Experience in Oncology, Full working proficiency in English, Proficiency in MS Office applications, Proficiency in MS Project
Nice to Have
Experience in GI
What You'll Do.
Oversee project teams
Coordinate project activities
Ensure process consistency
Ensure study milestones are met
Act as project management contact
Perform study status review
Perform progress reporting
Collect project status updates
Report project status updates
Develop project planning documents
Update project planning documents
Develop essential study documents
Update essential study documents
Develop project manuals/instructions
Update project manuals/instructions
Ensure project timelines are met
Ensure subject enrollment targets are met
Coordinate tracking systems maintenance
Coordinate site contractual startup
Coordinate budget negotiations
Establish communication lines
Supervise team performance
Identify resourcing issues
Escalate resourcing issues
Resolve resourcing issues
Identify performance issues
Escalate performance issues
Resolve performance issues
Conduct therapeutic area training
Supervise therapeutic area training
Prepare Investigator training presentations
Conduct Investigator training
Ensure team compliance with training matrix
Perform field training of Monitors
Supervise preparation of site visits
Supervise conduct of site visits
Supervise reporting of site visits
Oversee investigator payments
Oversee site payments
Oversee CRF data retrieval
Oversee query resolution process
Supervise team preparation for audits
Supervise team preparation for inspections
Supervise resolution of audit findings
Supervise resolution of inspection findings
Coordinate conduct of supervised monitoring visits
Review site visit reports
Ensure monitoring standards are met
Ensure reporting standards are met
Coordinate preparation of Regulatory submissions
Coordinate preparation of Ethics Committee submissions
Oversee safety information flow
Participate in feasibility research
Review project related expenses
Approve project related expenses
How You'll Work.
Team & Collaboration
Project teams; PSI support services; Clinical project team members; Project team members; Monitors; Investigators; Regulatory; Ethics Committee
Communication Scope
Presentation skills; Customer-service skills
Process & Methodology
Project management, Clinical trial management, Planning, Implementation, Reporting, Timeline management, Budget negotiation, Performance management, Training, Monitoring, Audits, Inspections, Submissions
Full Job Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. We work on the front-line of medical science, changing lives, and bringing new medicines to those who need them. If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. The Regional Project Lead is a senior level clinical trial manager who oversees, manages, and coordinates activities of project teams in designated countries and ensures consistency of Clinical Operations processes across regions. They ensure meeting study milestones are met by the project team on a country and regional level. * Ensures planning, implementation, and management of projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents (e.g., PSI QSDs or Sponsor QMS documents) * Acts as primary or secondary project management contact for the project team and PSI support services in designated countries * Performs study status review and progress reporting (if delegated by the Project Manager) * Collects and reports project status updates for designated regions, both internally and externally * Develops and updates project planning documents, essential study documents and project manuals/ instructions * Manages and reports on Key Performance Indicators (KPIs) for designated countries and clinical project team members * Ensures that the project timelines and subject enrollment targets are met in designated countries * Coordinates maintenance of study-specific and corporate tracking systems * Coordinates site contractual startup and budget negotiations * Establishes communication lines within the project team and supervises clinical project team members’ performance * Identifies, escalates and resolv
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