Country Start-Up Specialist – Clinical Trials

Syneos Health, Inc.; Illinois; On-site; USD 56,000 - 96,000; Full time

Benefits offered by this job

Company car/allowance

Medical/Dental/Vision benefits

401k with company match

Employee Stock Purchase Plan

Bonuses/Commissions

Paid time off (PTO) & sick time

Job summary

Syneos Health, Inc. is seeking a Country Start-Up Specialist - Maintenance to coordinate start-up activities at the country level, manage regulatory submissions, essential documents, and site activation for clinical studies in the United States.

The role emphasizes adherence to ICH-GCP, timelines, and cross-functional collaboration with sponsors and sites. You will monitor submission timelines, ensure documentation quality, and support continuous improvement of SSU processes within the country,

Qualifications

• Experience in Clinical Research, Study Start-Up, Regulatory Affairs, Clinical Operations, or related functions.
• Demonstrated experience managing country start-up activities, including regulatory and ethics submissions, essential document collection, and study activation processes.
• Strong understanding of ICH-GCP guidelines and local regulatory requirements.

Responsibilities

• Responsible for country-level quality deliverables with oversight and adherence to timelines.
• Monitors basic financial aspects and tracks hours/tasks per contract.
• Ensures SOPs/WIs are followed and training records remain up-to-date.
• Supports continuous quality improvement of Site Start-Up components at country level.
• Submits and manages regulatory documents to ECs, RA authorities, and TMF as required.
• Acts as liaison between investigational sites and functional leads during start-up and activation.
• Oversees end-to-end site activation and maintains regulatory compliance throughout study lifecycle.

Skills

Clinical Research

Study Start-Up

Regulatory Affairs

Clinical Operations

Project Management

Stakeholder coordination

Regulatory submissions

Job description

Syneos Health, Inc. is seeking a Country Start-Up Specialist - Maintenance to coordinate start-up activities at the country level, manage regulatory submissions, essential documents, and site activation for clinical studies in the United States.

The role emphasizes adherence to ICH-GCP, timelines, and cross-functional collaboration with sponsors and sites. You will monitor submission timelines, ensure documentation quality, and support continuous improvement of SSU processes within the country,