Lead Clinical Research Associate

About the role

As a Lead Clinical Research Associate at PSI, you will provide leadership and oversight for clinical monitoring activities across a country or region. The role focuses on ensuring high‑quality execution, regulatory compliance, and timely delivery of trial milestones while operating largely through remote supervision.

Key responsibilities

• Monitor project timelines, patient enrollment, data cleaning and implement corrective actions.
• Review monitoring visit reports and ensure compliance of regional monitors.
• Serve as primary communication link between monitors, site management, regional leads and project managers.
• Lead country‑level project calls, provide status updates and prepare training materials.
• Supervise source data verification, data query resolution and risk management at site level.
• Oversee investigational product handling, clinical supplies management and reconciliation of study documents.
• Coordinate safety information flow, protocol deviation reporting and central monitoring observations.
• Support site feasibility, startup, contracting, payments and audit preparation.
• Guide the project team in CAPA development and implementation.

Required profile

• Proven experience leading clinical monitoring teams in a CRO or pharmaceutical environment.
• Strong understanding of GCP, regulatory requirements and clinical trial processes.
• Excellent communication and mentorship abilities to coordinate cross‑functional teams.
• Ability to work independently with minimal travel, providing remote oversight.

Required skills

• Source data verification (SDV) processes.
• Investigational product (IP) management.
• Clinical trial documentation (ISF/TMF) reconciliation.
• Central monitoring and query resolution.