Clinical Trials Operations Lead & Regulatory Manager

Nnphi; San Juan (PR); On-site; USD 85,000 - 105,000; Full time

Job summary

PRCCI in San Juan, PR seeks a Clinical Trials Site Manager to oversee the day-to-day operations of the PRCCI Clinical Research Center. The role ensures compliant, timely execution of studies with a focus on participant safety and data integrity.

You will drive regulatory compliance, SOP development, staff supervision, and effective collaboration with sponsors, investigators, and site personnel across US Puerto Rico.

Qualifications

• Thorough knowledge of GCP, ICH guidelines, FDA regulations, IRB requirements, and HIPAA.
• Experience overseeing industry-sponsored clinical trials.
• Proficiency with clinical research tech platforms and ability to adapt to new software.
• Strong organizational, analytical, and communication skills in a fast-paced environment.

Responsibilities

• Oversee day-to-day operations of multiple clinical trials from start-up to close-out.
• Ensure trials are conducted per approved protocols and regulatory requirements.
• Develop and maintain SOPs and ensure proper documentation and CAPAs.
• Lead site staff, coordinate budgets, and manage resources.
• Coordinate sponsor visits, audits, and regulatory inspections.

Skills

Regulatory compliance

Leadership

Communication (EN/ES)

Project management

Data quality & integrity

Education

Advanced degree in life sciences

Tools

CTMS

EDC systems

Document Management Systems

Job description

PRCCI in San Juan, PR seeks a Clinical Trials Site Manager to oversee the day-to-day operations of the PRCCI Clinical Research Center. The role ensures compliant, timely execution of studies with a focus on participant safety and data integrity.

You will drive regulatory compliance, SOP development, staff supervision, and effective collaboration with sponsors, investigators, and site personnel across US Puerto Rico.