Full-Time Regional Project Lead

Regional Project Lead manages and coordinates project teams in designated countries, ensuring consistent Clinical Operations processes across regions.

Responsibilities include:

1. Meeting study milestones on country and regional levels.
2. Ensuring project planning, implementation, and management comply with industry regulations (e.g., ICH-GCP), essential study documents, and controlled documents (e.g., PSI QSDs or Sponsor QMS documents).
3. Acting as primary/secondary project management contact for project teams and PSI support services.
4. Performing study status reviews and progress reporting (if delegated).
5. Collecting and reporting project status updates internally and externally.
6. Developing and updating project planning documents, essential study documents, and project manuals.
7. Managing and reporting on Key Performance Indicators (KPIs) for designated countries and clinical project team members.
8. Ensuring project timelines and subject enrollment targets are met.
9. Coordinating study-specific and corporate tracking systems.
10. Coordinating site contractual startup and budget negotiations.
11. Establishing communication lines within project teams and supervising clinical project team member performance.
12. Identifying, escalating, and resolving resourcing and performance issues.
13. Conducting and supervising therapeutic area training (if delegated).
14. Preparing presentations and conducting Investigator training.
15. Ensuring team compliance with project-specific training matrix.
16. Performing field training for Monitors.
17. Supervising site selection, site initiation, routine monitoring, and closeout visits.
18. Overseeing investigator and site payments, CRF data retrieval/upload, monitoring, and query resolution.
19. Supervising project team preparation for study audits/inspections and resolving findings.
20. Coordinating supervised monitoring visits.
21. Reviewing site visit reports and ensuring monitoring and reporting standards are met.
22. Coordinating Regulatory and Ethics Committee submissions and notifications (initial and follow-up).
23. Overseeing safety information flow and participating in feasibility research.
24. Reviewing/approving project-related expenses and timesheets (if delegated).

Qualifications include:

• College/University degree in Life Sciences or equivalent.
• 4+ years experience in Clinical Research and site monitoring.
• 2+ years experience as a Study Manager or Lead, with supervisory experience.
• Oncology experience preferred.
• Full working proficiency in English.
• Proficiency in MS Office applications (including MS Project).
• Strong communication, presentation, and customer service skills.
• Negotiation and relationship-building abilities.
• Team-building, leadership, and organizational skills.

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