Responsibilities
- Leads, directs, and aligns project team activities in assigned countries to maintain uniformity in clinical operations processes across regions
- Monitors and verifies achievement of country- and region-level study milestones
- Ensures project planning, execution, and oversight adhere to regulatory standards, ICH-GCP guidelines, and relevant study and quality documentation
- Serves as primary or backup point of contact for project teams and internal support functions in designated countries
- Conducts review of study progress and delivers status updates when authorized by the Project Manager
- Gathers and communicates project status information for internal and external stakeholders in specified regions
- Creates and maintains project plans, core study documents, and procedural manuals
- Tracks and reports performance metrics for clinical team members and countries under supervision
- Ensures adherence to project timelines and participant recruitment goals in assigned countries
- Coordinates the use and upkeep of study-specific and organizational tracking tools
- Manages site contract initiation and financial negotiations
- Establishes communication protocols within the team and oversees clinical team performance
- Recognizes, reports, and resolves staffing and performance challenges
- Delivers or supervises disease-area-specific training for project staff when delegated
- Develops and leads training sessions for Investigators
- Ensures team adherence to project-specific training requirements
- Provides on-site or field-based training for Monitors based on study demands
- Manages the preparation, execution, and documentation of site selection, initiation, monitoring, and closeout visits
- Oversees investigator compensation, CRF data handling, and query resolution processes
- Guides team readiness for audits and inspections and ensures timely resolution of findings
- Coordinates supervised monitoring activities
- Reviews monitoring visit reports and verifies compliance with quality standards
- Manages preparation and submission of regulatory and ethics documentation
- Monitors safety data flow and contributes to feasibility assessments
- Approves project-related costs and timesheets when authorized by the Project Manager
