Clinical Trials Site Lead — Operations & Compliance

Automatic Data Processing, Inc.; San Juan (PR); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

PRCCI seeks a Clinical Trials Site Manager in San Juan to oversee day-to-day site operations, ensure regulatory compliance, and manage staff across multiple trials. The role emphasizes coordination with sponsors, investigators, and regulatory bodies to maintain data integrity and participant safety.

Responsibilities include managing study protocols, SOPs, budgets, and enrollment processes, while promoting continuous improvement and project leadership within a dynamic clinical research

Qualifications

• Proven ability to supervise clinical research staff and coordinate across multiple trials.
• Strong knowledge of GCP, ICH, FDA regulations and IRB requirements.
• Ability to manage study protocols, SOPs, training records, and documentation.

Responsabilités

• Oversee day-to-day site operations for multiple trials from start-up to close-out.
• Lead staff supervision, performance evaluations, and professional development.
• Ensure regulatory compliance and timely regulatory submissions and inspections.
• Coordinate sponsor monitoring visits, site assessments, and communication with sponsors and investigators.
• Collaborate to maintain data integrity, safety, and trial quality.

Connaissances

Leadership

Regulatory knowledge

Study coordination

Budget management

Formation

Advanced degree in life sciences

Description du poste

PRCCI seeks a Clinical Trials Site Manager in San Juan to oversee day-to-day site operations, ensure regulatory compliance, and manage staff across multiple trials. The role emphasizes coordination with sponsors, investigators, and regulatory bodies to maintain data integrity and participant safety.

Responsibilities include managing study protocols, SOPs, budgets, and enrollment processes, while promoting continuous improvement and project leadership within a dynamic clinical research