Remote Clinical Operations Lead

Fortrea; Durham (NC); Remote; USD 100,000 - 113,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life

STD/LTD

401(K)

ESPP

PTO/FTO

Company bonus

Job summary

Fortrea's FSP team seeks a Clinical Operations Manager to lead remote, US-based countryclinical activities, regulatory and financial compliance, and start-up deliverables. You will oversee budgets, contracts, local submissions, and language materials while coordinating with IRB/IEC, regulators, vendors, and country managers to ensure on-time study milestones.

Strong organizational skills, attention to detail, and the ability to manage payments and risk are essential.

Qualifications

• University degree or allied health certification.
• 4+ years clinical research experience in pharmaceutical or CRO industries.
• Knowledge of ICH Guidelines and GCP; regulatory requirements familiarity.
• Understanding of the drug development process.
• Fluent in local language and English.

Responsibilities

• Own country budgets and analyze clinical and financial contracts.
• Oversee country submissions, approvals, and local language materials.
• Work with IRB/IEC and Regulatory Authorities for protocol-related interactions.
• Manage country deliverables, timelines, and results to meet commitments.
• Contribute to local SOP development and cross-functional collaboration.
• Oversee country payments, invoicing, and payment reconciliation.
• Coordinate with vendors, sites, and regional operations to align timelines.
• Maintain country regulatory, safety, regulatory, and finance system updates.
• Lead and develop junior staff and manage risk locally.

Skills

Organizational skills

Time management

Communication skills

Self-motivation

Detail oriented

Multitasking

Adaptability

Computer skills

Leadership

English proficiency

Education

Life sciences degree

Healthcare certification

Job description

Fortrea's FSP team seeks a Clinical Operations Manager to lead remote, US-based countryclinical activities, regulatory and financial compliance, and start-up deliverables. You will oversee budgets, contracts, local submissions, and language materials while coordinating with IRB/IEC, regulators, vendors, and country managers to ensure on-time study milestones.

Strong organizational skills, attention to detail, and the ability to manage payments and risk are essential.