Clinical Regional Project Lead
PSI CRO · Buenos Aires
Descripcion del puesto
About the role
PSI is seeking a senior Clinical Regional Project Lead to oversee and coordinate clinical trial activities across designated countries. The role ensures consistent Clinical Operations processes, drives study milestones, and supports both internal teams and external sponsors.
Key responsibilities
- Plan, implement, and manage projects in compliance with ICH‑GCP, industry regulations, and sponsor quality systems.
- Act as primary or secondary project management contact for designated regions.
- Collect and report project status updates, develop planning documents, and manage KPIs.
- Coordinate site contractual startup, budget negotiations, and investigator payments.
- Supervise site selection, initiation, monitoring, and close‑out visits, including audit preparation.
- Oversee regulatory and ethics committee submissions and safety information flow.
- Identify, escalate, and resolve resourcing and performance issues.
- Deliver training to investigators, monitors, and the project team as required.
Required profile
- College or University degree in Life Sciences or an equivalent combination of education and experience.
- Prior experience in clinical project management within a CRO or pharmaceutical environment.
- Demonstrated ability to manage multi‑country clinical studies and lead cross‑functional teams.
Required skills
What we offer
- Opportunity to work with a leading CRO with more than 30 years of industry experience.
- Exposure to a variety of therapeutic indications and international projects.
- Professional development in a stable yet innovative environment.
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