Clinical Research Manager: Regulatory & Trials Lead

Fortrea; Santiago; On-site; CLP 120,000,000 - 180,000,000; Full time

Job summary

Fortrea in Chile seeks a Country Operations Leader for local clinical trial execution, regulatory compliance, and cross-functional coordination. You will oversee country commitments, drive timelines, manage budgets, and ensure adherence to ICH/GCP and local rules while representing the client with investigators and external partners.

The role demands strong leadership, stakeholder engagement, and the ability to work across PV, Regulatory, Medical Affairs, and external CROs in a virtual,

Qualifications

• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
• In lieu of the above requirement, candidates with a minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered.
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
• Thorough understanding of the drug development process.
• Fluent in local office language and in English, both written and verbal (Spanish and English).
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Focus on Customer – Manager; Innovate and Change – Manager; Pursue Scientific and Process Excellence – Manager; Work with Others – Manager; Achieve Results – Manager.
• Minimum of six-eight (6-8) years of clinical research experience.

Responsibilities

• PERFORMANCE - Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• MANAGEMENT - POC for assigned protocols. Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local CO roles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated).
• QUALITY OVERSIGHT - Responsible for quality and compliance in assigned protocols in country. Oversees CRAs and CTCs on assigned projects. Oversees training compliance. Performs quality control visits. Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed. Oversees associate CRMs assigned to the Client and work on training needs in collaboration with functional vendor.
• EXTERNAL CUSTOMER FACING - Responsible for collaboration with functional outsourcing vendors, investigators, and other external partners. Oversees country and site validations, site recruitment in assigned protocols. Responsible for clinical trial education to sites. Country POC for programmatically outsourced trials for assigned protocols.
• INTERNAL COLLABORATION and STRATEGY - Collaborates internally with local PV, Regulatory, GMA/GHH to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations.
• All other duties as needed or assigned.

Skills

English fluency

Clinical trials

Leadership

Regulatory knowledge

Stakeholder mgmt

Cross-functional

Decision making

Budget mgmt

Education

Life sciences degree

Regulatory/IRB knowledge

Tools

MS Office

eTMF

Job description

Fortrea in Chile seeks a Country Operations Leader for local clinical trial execution, regulatory compliance, and cross-functional coordination. You will oversee country commitments, drive timelines, manage budgets, and ensure adherence to ICH/GCP and local rules while representing the client with investigators and external partners.

The role demands strong leadership, stakeholder engagement, and the ability to work across PV, Regulatory, Medical Affairs, and external CROs in a virtual,