Senior Clinical Research Associate (Level I)

About the role

Join a global CRO team that supports leading pharmaceutical and biotech companies across more than 100 countries. As a Senior Clinical Research Associate (Level I), you will oversee remote and on‑site monitoring activities, ensuring trials are conducted in compliance with protocols, ICH‑GCP guidelines, and regulatory requirements.

Key responsibilities

• Perform risk‑based monitoring visits, applying root‑cause analysis to identify and resolve site process failures.
• Verify data accuracy through source data verification (SDR), source data review (SDV), and case report form (CRF) review.
• Assess investigational product inventory and documentation.
• Document observations, generate monitoring reports, and communicate findings to clinical management.
• Maintain regular contact with sites to ensure protocol adherence and timely data entry.
• Support investigator payment processes and contribute to investigator meetings.
• Update study systems such as the Clinical Trial Management System (CTMS) and perform quality checks on generated reports.

Required profile

• Experience in clinical monitoring and site management within pharmaceutical or biotech trials.
• Strong understanding of ICH‑GCP, regulatory compliance, and SOPs.
• Ability to conduct root‑cause analysis and implement corrective actions.
• Excellent written communication for reporting and escalation.

Required skills

• ICH‑GCP compliance
• Clinical Trial Management System (CTMS) usage
• Source Data Verification (SDV) and Source Data Review (SDR)
• Case Report Form (CRF) review
• Root‑cause analysis