Clinical Regional Project Lead

PSI CRO·Mexico City, CDMX, Mexico

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About the role

Hybrid senior clinical trial management role in Mexico City coordinating regional project activities, milestones, monitoring, regulatory and ethics submissions, site operations, training, payments, data flow, audits and performance. Requires a Life Sciences degree or equivalent education/training/experience, clinical research and on-site monitoring experience, prior US monitoring, Study Manager/Clinical Trial Manager experience, oncology experience, English proficiency, and MS Office/MS Project skills. 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, Study management/clinical trial management, Project activity supervision, Oncology, US clinical monitoring, MS Office, MS Project, Communication, Presentation, Customer service, Negotiation, Relationship building, Team building, Leadership, Organization
• Required language: English

Opportunity details

• Workplace: Hybrid
• Posted: Oct 14, 2026
• Original advert language: English

Full vacancy

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Employer’s role description

Job title: Clinical Regional Project Lead

Location: Mexico City, CDMX, Mexico

Employment type: Full-time

Workplace type: Hybrid

Company Description

PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

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

Qualifications

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