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.

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 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)

Qualifications

College/University degree in Life Sciences or an equivalent combination of education, training & experience is required

Prior experience in Clinical Research and on-site monitoring is required

Prior experience monitoring within the US

Experience as a Study Manager/Clinical Trial Manager with the ability to supervise project activities as a Regional Lead or equivalent is required

Experience in Oncology is required

Experience in GI is preferred Full working proficiency in English

Proficiency in MS Office applications, including MS Project

Communication, presentation and customer-service skills

Ability to negotiate and build relationships at all levels

Team building, leadership and organizational skills

Additional Information

Advance your career in clinical research and lead challenging full-service projects on the country/regional level while growing with a rapid company, that puts its people first! You will get hands-on involvement in every aspect of the study.

📌 Clinical Regional Project Lead (Buenos Aires)
🏢 Psi Cro
📍 Buenos Aires