Clinical Trials Site Lead & Regulatory Manager

Puerto-Rico-Science-Technology-; San Juan (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Puerto Rico Consortium for Clinical Investigation (PRCCI) seeks a Clinical Trials Site Manager to oversee day-to-day operations of the PRCRI Clinical Research Center in San Juan, PR. The role combines site management with regulatory oversight to ensure compliance with GCP, ICH, FDA, and IRB requirements.

The CSM will manage staff, budgets, study protocols, participant safety, data quality, and sponsor communications, contributing to PRCCI’s clinical research mission.

Qualifications

• Advanced degree in life sciences required.
• Experience managing clinical trials at an industry-sponsored site.
• Excellent communication and leadership skills.

Responsibilities

• Oversee day-to-day site operations for multiple trials from start-up to close-out.
• Ensure compliance with GCP, ICH, FDA and IRB requirements.
• Develop and maintain SOPs, training, and operational documents.
• Manage site resources, facilities, equipment, and budgets.
• Lead staff supervision, mentorship, and performance evaluations.

Education

Advanced degree in life sciences

Tools

CTMS

EDC systems

Document Management

Job description

Puerto Rico Consortium for Clinical Investigation (PRCCI) seeks a Clinical Trials Site Manager to oversee day-to-day operations of the PRCRI Clinical Research Center in San Juan, PR. The role combines site management with regulatory oversight to ensure compliance with GCP, ICH, FDA, and IRB requirements.

The CSM will manage staff, budgets, study protocols, participant safety, data quality, and sponsor communications, contributing to PRCCI’s clinical research mission.