Lead, Clinical Research & Local Regulatory Compliance

Fortrea; Santiago; Sur place; CLP 35 000 000 - 55 000 000; Plein temps

Résumé du poste

Fortrea in Chile seeks an experienced Clinical Operations Leader to oversee country-level trials in alignment with ICH/GCP and local regulations. You will manage cross-functional teams, coordinate with investigators and vendors, and ensure high-quality execution of study commitments.

The role requires strong leadership, regulatory knowledge, and the ability to collaborate with regional and global teams while maintaining training and quality standards across country operations.

Qualifications

• University degree in life sciences or related allied health field, or equivalent clinical research experience.
• Four+ years clinical research experience if no degree.
• Strong knowledge of ICH/GCP and local regulatory requirements.
• Fluent in local language and English.
• Ability to lead and develop junior staff.
• Excellent communication and organizational skills.

Responsabilités

• Accountable for performance and compliance for assigned protocols in country.
• POC for assigned protocols; proactively drives execution and tracks deliverables, timelines, and results.
• Quality oversight: oversee CRAs and CTCs, training compliance, QC visits, and monitoring visit reports.
• Collaborate with vendors, investigators, and external partners; oversee country/site validations, site selection, and recruitment.
• Internal collaboration with local PV, Regulatory, GMA/GHH; support regional and corporate strategy.
• All other duties as needed or assigned.

Connaissances

Communication skills

Organization & time management

Self-motivation

Teamwork

Attention to detail

Multi-tasking

Computer skills

Leadership

Adaptability

Formation

Life sciences degree

Nursing certification

Medical/Clinical lab tech certification

Description du poste

Fortrea in Chile seeks an experienced Clinical Operations Leader to oversee country-level trials in alignment with ICH/GCP and local regulations. You will manage cross-functional teams, coordinate with investigators and vendors, and ensure high-quality execution of study commitments.

The role requires strong leadership, regulatory knowledge, and the ability to collaborate with regional and global teams while maintaining training and quality standards across country operations.