Regional Project Lead

PSI CRO•Remote, US

13h

About The Position

The Regional Project Lead drives successful delivery of clinical trials across multiple countries. The role partners with Project Managers, CRAs, sponsors, and cross-functional teams to ensure efficient study execution, mentor project teams, and maintain high quality standards. Regional Project Leads may act as primary or secondary project management contacts for designated countries and support study planning, oversight, reporting, training, monitoring, regulatory submissions, and site operations.

Requirements

College or university degree in Life Sciences, or an equivalent combination of education, training, and experience.
Prior experience in clinical research and independent on-site monitoring.
Experience as a Study Manager or Clinical Trial Manager, with the ability to supervise project activities as a Regional Lead or equivalent.
Therapeutic expertise in Oncology and/or Gastroenterology.
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.
Must not require a work visa for employment or continued employment now or in the future.

Responsibilities

Ensure planning, implementation, and management of projects comply with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents.
Act as the primary or secondary project management contact for the project team and PSI support services in designated countries.
Review study status and report progress when delegated by the Project Manager.
Collect and report project status updates for designated regions internally and externally.
Develop and update project planning documents, essential study documents, and project manuals or instructions.
Manage and report on KPIs for designated countries and clinical project team members.
Ensure project timelines and subject enrollment targets are met in designated countries.
Coordinate maintenance of study-specific and corporate tracking systems.
Coordinate site contractual startup and budget negotiations.
Establish project-team communication lines and supervise clinical project team members' performance.
Identify, escalate, and resolve resourcing and performance issues.
Conduct and supervise therapeutic-area training for the project team when delegated by the Project Manager.
Prepare presentations and conduct training for Investigators.
Ensure team compliance with the project-specific training matrix.
Provide project-specific field training for Monitors.
Supervise preparation, conduct, and reporting of site selection, site initiation, routine monitoring, and closeout visits.
Oversee investigator and site payments, CRF data retrieval and upload, monitoring, and query resolution.
Supervise project-team preparation for study audits and inspections and resolution of findings.
Coordinate supervised monitoring visits.
Review site visit reports and ensure monitoring and reporting standards are met.
Coordinate initial and follow-up Regulatory and Ethics Committee submissions and notifications.
Oversee safety information flow and participate in feasibility research.
Review and approve project-related expenses and timesheets when delegated by the Project Manager.