About the job
The Regional Project Lead is responsible for the strategic management and coordination of project teams across designated countries, ensuring uniformity in Clinical Operations processes across all regions. This role is pivotal in ensuring that the project team meets essential study milestones at both country and regional levels.
- Oversees the planning, implementation, and management of projects, ensuring compliance with industry standards, including ICH-GCP and essential study documents.
- Serves as the primary or secondary contact for project management and PSI support services in assigned countries.
- Reviews study status and provides progress reports as delegated by the Project Manager.
- Collects and communicates project status updates for designated regions internally and externally.
- Develops and maintains project planning documents, essential study documents, and project manuals/instructions.
- Monitors and reports on Key Performance Indicators (KPIs) for clinical project team members across designated countries.
- Ensures project timelines and subject enrollment targets are achieved in assigned countries.
- Coordinates the maintenance of study-specific and corporate tracking systems.
- Facilitates site contract initiation and budget negotiations.
- Establishes effective communication channels within the project team and supervises team performance.
- Identifies, escalates, and resolves resource and performance challenges.
- Conducts and supervises training for the project team related to therapeutic areas as delegated.
- Prepares and conducts training sessions for Investigators.
- Ensures compliance with the project-specific training matrix among the team.
- Provides field training for Monitors tailored to project needs.
- Oversees the preparation, execution, and reporting of site selection, initiation, routine monitoring, and closeout visits.
- Manages investigator and site payments, CRF data retrieval, upload processes, and query resolution.
- Supervises project team readiness for study audits and inspections, ensuring resolution of findings.
- Coordinates supervised monitoring visits and reviews site visit reports to ensure compliance with monitoring standards.
- Manages the preparation of initial and follow-up Regulatory and Ethics Committee submissions.
- Oversees the flow of safety information and participates in feasibility studies.
- Reviews and approves project-related expenses and timesheets as delegated.