Responsibilities
- Tracks project schedules, patient recruitment progress, and data quality, implementing corrective and preventive actions as needed.
- Reviews monitoring visit reports across all visit types and ensures monitors meet reporting requirements in the region.
- Serves as the primary communication link between monitors, site management staff, regional leads, and project managers.
- Leads country-level project team meetings and delivers regular status updates to regional or project management leads.
- Develops and delivers project-specific training materials under the guidance of senior project leadership.
- Oversees source data verification, resolves site-level data queries, and manages site-specific study risks.
- Manages the handling, tracking, reconciliation, and return of investigational products and study supplies within the assigned region.
- Reviews critical study documentation and ensures proper maintenance and reconciliation of Investigator Site Files and Trial Master Files at site and regional levels.
- Maintains data accuracy and regulatory compliance at individual study sites.
- Supports site feasibility assessments, site selection, and initiation activities.
- Guides monitors in resolving data queries, including those identified through central monitoring.
- Coordinates the reporting of safety events and deviations from protocol or standard procedures.
- Manages clinical supply logistics with vendors at country and regional levels.
- Ensures timely updates to corporate and study-specific tracking systems.
- Plans and executes supervised monitoring visits in coordination with the project team.
- Oversees site contract execution and payment processes managed by the project team.
- Conducts ongoing assessments of data quality and compliance across the region.
- Performs pre-audit site visits, participates in audits when required, and manages follow-up actions for audit findings.
- Guides the development and implementation of corrective and preventive action plans.
- Coordinates the review, documentation, and reporting of process deviations across the project team.
- Conducts training and authorization visits for new monitors and mentors recently promoted lead CRAs.
- Presents training content at investigator meetings and study-related events.
- Ensures site-level recruitment goals and study timelines are clearly defined, tracked, and achieved.
- Maintains accurate and timely communication with sites regarding adverse events and procedural deviations.
- Supervises site management staff in managing document flow and laboratory supply logistics between sites and central or regional labs.
Work Arrangement
Remote (Country)
