Full-Time Regional Project Lead

Regional Project Lead manages and coordinates project team activities in designated countries.

Ensures consistency of Clinical Operations processes across regions, meeting study milestones. Complies with industry regulations (ICH-GCP) and essential documents (e.g., PSI QSDs or Sponsor QMS documents).

Acts as primary/secondary project management contact for project team and PSI support services.

Performs study status review and progress reporting (if delegated).

Collects and reports project status updates internally and externally for designated regions.

Develops and updates project planning documents, essential study documents, and project manuals/instructions.

Manages and reports on KPIs for designated countries and project team members.

Ensures 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 performance.

Identifies, escalates, and resolves resourcing and performance issues.

(If delegated) Conducts and supervises therapeutic area training of the project team.

(If delegated) Prepares presentations and conducts training of Investigators.

Ensures team compliance with project-specific training matrix.

Performs field training of Monitors.

Supervises preparation, conduct, and reporting of site selection, site initiation, routine monitoring, and closeout visits.

Oversees investigator and site payments, CRF data retrieval/upload and monitoring, and query resolution.

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 safety information flow and participates in feasibility research.

(If delegated) Reviews/approves project-related expenses and timesheets.

Qualifications:

College/University degree in Life Sciences or equivalent experience. 4+ years experience in Clinical Research and site monitoring.

2+ years experience as Study Manager/Lead with ability to supervise project activities.

Oncology experience preferred.

Full working proficiency in English. Proficiency in MS Office applications, including MS Project.

Communication, presentation, and customer service skills.

Negotiation and relationship-building skills.

Team-building, leadership, and organizational skills.

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