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 meeting study milestones are met by the project team on a country and regional level.
1. Ensures planning, implementation, and management of projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents (e.g., PSI QSDs or Sponsor QMS documents)
2. Acts as primary or secondary project management contact for the project team and PSI support services in designated countries
3. Performs study status review and progress reporting (if delegated by the Project Manager)
4. Collects and reports project status updates for designated regions, both internally and externally
5. Develops and updates project planning documents, essential study documents and project manuals/ instructions
6. Manages and reports on Key Performance Indicators (KPIs) for designated countries and clinical project team members
7. Ensures that the project timelines and subject enrollment targets are met in designated countries
8. Coordinates maintenance of study-specific and corporate tracking systems
9. Coordinates site contractual startup and budget negotiations
10. Establishes communication lines within the project team and supervises clinical project team members’ performance
11. Identifies, escalates and resolves resourcing and performance issues
12. Conducts and supervises therapeutic area training of the project team (if delegated by the Project Manager)
13. Prepares presentations and conducts training of Investigators
14. Ensures team compliance with project-specific training matrix
15. Performs field training of Monitors tailored to the project needs
16. Supervises preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits
17. Oversees investigator and site payments, as well as CRF data retrieval/ upload and monitoring and the query resolution process
18. Supervises project team preparation for study audits/ inspections and resolution of audit/ inspection findings
19. Coordinates conduct of supervised monitoring visits
20. Reviews site visit reports and ensures monitoring and reporting standards are met
21. Coordinates preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications
22. Oversees the safety information flow and participates in feasibility research
23. Reviews/ approves project related expenses and timesheets (if delegated by the Project Manager)
Qualifications
24. College/University degree in Life Sciences or an equivalent combination of education, training & experience
25. Significant experience in Clinical Research and site monitoring
26. Experience as a Study Manager or Lead with the ability to supervise project activities as a Regional Lead or equivalent
27. Experience in Oncology is preferred.
28. Full working proficiency in English
29. Proficiency in MS Office applications, including MS Project
30. Communication, presentation and customer-service skills
31. Ability to negotiate and build relationships at all levels
32. Team-building, leadership and organizational skills
Additional Information
Advance your career in clinical research and lead challenging full-service projects on the country/regional level while growing with a rapid company, that puts its people first! You will get hands-on involvement in every aspect of the study.