Remote Country Start-Up Specialist – Regulatory & Activation

Syneos Health, Inc.; Northern (KY); Hybrid; USD 56,000 - 96,000; Full time

Benefits offered by this job

Company car/allowance

Health benefits

401k match

Stock purchase plan

Bonuses

PTO & sick time

Job summary

Syneos Health seeks a Country Start-Up Specialist for maintenance in a remote USA-based role. You will manage country start-up submissions, regulatory packages, and essential document collection across sites, ensuring alignment with SOPs and project timelines.

The role emphasizes collaboration with sponsors, CROs, and regulatory authorities, maintaining TMF quality and supporting site activation end-to-end.

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 committee submissions, essential document collection, and study activation processes.
• Experience supporting study maintenance activities, including protocol amendments, continuing reviews, safety submissions, renewals, and ongoing regulatory compliance.

Responsibilities

• Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules with moderate oversight from the SSU Country Manager.
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
• Reviews and complies with SOPs and WI in a timely manner, keeps training records updated and ensures timesheet compliance.
• Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level.

Skills

Clinical research

Study Start-Up

Regulatory affairs

Project management

Communication skills

Organizational skills

Stakeholder management

Cross-functional collaboration

Tools

Microsoft Office

Job description

Syneos Health seeks a Country Start-Up Specialist for maintenance in a remote USA-based role. You will manage country start-up submissions, regulatory packages, and essential document collection across sites, ensuring alignment with SOPs and project timelines.

The role emphasizes collaboration with sponsors, CROs, and regulatory authorities, maintaining TMF quality and supporting site activation end-to-end.