Clinical Regional Project Lead

PSI CRO·São Paulo, SP, Brazil

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About the role

Remote senior clinical trial management role coordinating project activities across designated countries and regions. Responsibilities include planning, regulatory and ethics submissions, site startup, monitoring oversight, team supervision, training, KPI and timeline management, payments, data and query oversight, and audit readiness. Requires a Life Sciences degree or equivalent education, training and experience, clinical research and on-site monitoring experience, US monitoring experience, oncology experience, and Study Manager/Clinical Trial Manager leadership experience. GI experience is preferred.

Key requirements

• College/University degree in Life Sciences or an equivalent combination of education, training & experience is required
• Required skills: Clinical research, On-site monitoring, US clinical trial monitoring, Study management or clinical trial management, Regional project leadership or equivalent project activity supervision, Oncology, MS Office, MS Project, Communication, Presentation, Customer service, Negotiation, Relationship building, Team building, Leadership, Organization
• Required language: English

Opportunity details

• Workplace: Remote
• Posted: Oct 13, 2026
• Original advert language: English

Full vacancy

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Employer’s role description

Job title: Clinical Regional Project Lead

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 resolves resourcing and performance issues
Conducts and supervises therapeutic area training of the project team (if delegated by the Project Manager)
Prepares presentations and conducts training of Investigators
Ensures team compliance with project-specific training matrix
Performs field training of Monitors tailored to the project needs
Supervises preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits
Oversees investigator and site payments, as well as CRF data retrieval/ upload and monitoring and the query resolution process
Supervises project team preparation for study audits/ inspections and resolution of audit/ inspection findings
Coordinates conduct of supervised monitoring visits
Reviews site visit reports and ensures monitoring and reporting standards are met
Coordinates preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications
Oversees the safety information flow and participates in feasibility research
Reviews/approves project related expenses and timesheets (if delegated by the Project Manager)

Clinical Regional Project Lead

About the role

Key requirements

Opportunity details

Full vacancy

Company Description

Job Description

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