Full-Time Regional Project Lead
PSI CRO is hiring a remote Full-Time Regional Project Lead. The career level for this job opening is Manager and is accepting Remote, US based applicants remotely. Read complete job description before applying.
PSI CRO
Job Title
Regional Project Lead
Posted
Career Level
Full-Time
Career Level
Manager
Locations Accepted
Remote, US
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Job Details
The Regional Project Lead manages and coordinates activities of project teams 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.
Acts as primary or secondary project management contact for the project team and PSI support services.
Performs study status review and progress reporting.
Collects and reports project status updates, 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).
Ensures that the project timelines and subject enrollment targets are met.
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.
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.
Requirements:
- College/University degree in Life Sciences or equivalent.
- Prior experience in Clinical Research (minimum 5 years) and on-site monitoring.
- Experience as a Study Manager/Clinical Trial Manager with the ability to supervise project activities as a Regional Lead or equivalent.
- Experience in Oncology is required, GI 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.
FAQs
What is the last date for applying to the job?
The deadline to apply for Full-Time Regional Project Lead at PSI CRO is
9th of January 2026
. We consider jobs older than one month to have expired.
Which countries are accepted for this remote job?
This job accepts [
Remote, US
] applicants. .
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