Regional Project Lead.

Job Description

The official title for this role will be Regional Project Lead.

The Regional Project Lead manages and coordinates activities of project teams in designated countries and ensures consistency of Clinical Operations processes across regions. They ensure that study milestones are met by the project team at both country and regional levels.

Responsibilities include:

1. Ensuring planning, implementation, and management of projects in compliance with industry regulations, ICH-GCP, and applicable study documents.
2. Acting as primary or secondary project management contact for the project team and support services in designated countries.
3. Performing study status reviews and progress reporting (if delegated by the Project Manager).
4. Collecting and reporting project status updates internally and externally.
5. Developing and updating project planning documents, study documents, and manuals.
6. Managing and reporting on Key Performance Indicators (KPIs).
7. Ensuring project timelines and subject enrollment targets are met.
8. Coordinating maintenance of tracking systems.
9. Managing site contractual startup and budget negotiations.
10. Establishing communication within the project team and supervising team members’ performance.
11. Identifying, escalating, and resolving resourcing and performance issues.
12. Conducting therapeutic area training and preparing presentations for investigators.
13. Ensuring team compliance with training requirements.
14. Performing field training of monitors.
15. Supervising site visits and overseeing investigator and site payments, data retrieval, and monitoring.
16. Supervising preparation for audits/inspections and addressing findings.
17. Coordinating monitoring visits and ensuring reporting standards.
18. Managing regulatory submissions and safety information flow.
19. Reviewing and approving project expenses and timesheets (if delegated).

Qualifications

• College or university degree in Life Sciences or equivalent education and experience.
• Significant experience in Clinical Research and site monitoring.
• Experience as a Study Manager or Lead, supervising project activities as a Regional Lead or similar role.
• Experience in Oncology is preferred.
• Proficiency in English and MS Office applications, including MS Project.
• Strong communication, presentation, and customer service skills.
• Ability to negotiate and build relationships at all levels.
• Team-building, leadership, and organizational skills.

Additional Information

Advance your career in clinical research by leading challenging full-service projects at the country/regional level while growing with a rapid-growing company that values its people. You will be involved in every aspect of the study.