PSI CRO
pharmaceutical
ClinicalRegionalProjectLead
“Clinical Regional Project Lead at PSI CRO. Skills: project management, clinical operations, stakeholder management. Streamline activities of project teams. Ensure consistency of Clinical Operations processes”
What You'll Achieve.
Ensure meeting study milestones; Ensure that the project timelines and subject enrollment targets are met
Industry & Context.
What They're Looking For.
Must Have
Minimum 4 years’ site monitoring experience, at least 2 years’ experience as Lead Monitor, Experience supervising clinical project activities, leading clinical project teams, Full working proficiency in English and Chinese
Nice to Have
preferably in regional capacity, Experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or any rare disease indication
What You'll Do.
Streamline activities of project teams
Ensure consistency of Clinical Operations processes
Ensure meeting study milestones
Report study progress to clients
Act as project management contact
Perform study status review
Collect and report project status updates
Develop and update project planning documents
Ensure project timelines met
Ensure subject enrollment targets met
Coordinate maintenance of tracking systems
Oversee site selection
Oversee site contractual negotiations
Oversee site budget negotiations
Supervise project team training
Supervise site training
Perform field training of monitors
Ensure team compliance with training matrix
Supervise preparation of site visits
Supervise conduct of site visits
Supervise reporting of site visits
Review site visit reports
Ensure monitoring standards met
Ensure reporting standards met
Oversee investigator payments
Oversee site payments
Supervise project team preparation for audits
Supervise project team preparation for inspections
Oversee resolution of audit findings
Oversee resolution of inspection findings
Regional project oversight for APAC
How You'll Work.
Team & Collaboration
Act as project management contact for the project team; Act as project management contact for PSI support services; Supervise project team; Supervise project team preparation for study audits; Supervise project team preparation for study inspections
Communication Scope
Communication; presentation
Process & Methodology
project management, project planning, project timelines, study milestones, resource planning
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