Country Start-Up Specialist: Regulatory & Site Activation

1001 Syneos Health, LLC; Illinois; Hybrid; USD 56,000 - 96,000; Full time

Benefits offered by this job

Health benefits

Company car or car allowance

Company match 401k

Employee Stock Purchase Plan

Commissions/bonus

Flexible PTO

Job summary

Syneos Health in Illinois seeks a Country Start-Up Specialist - Maintenance to manage country-level start-up tasks, regulatory submissions, and center activation for clinical trials. You will ensure SOP compliance, track timelines, and coordinate with EC/RA authorities while supporting continuous improvement of SSU processes.

Responsibilities include preparing local EC and RA submissions, maintaining TMF documents, and acting as a liaison between sites and line managers.

Qualifications

• Experience in Clinical Research, Study Start-Up, Regulatory Affairs, Clinical Operations, or related functions.
• Strong project management and organizational skills.
• Strong written and verbal communication and interpersonal skills.

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.
• Works within forecasted submission/approval timelines and tracks milestones in real time; investigates delays and provides contingency plans.
• Monitors basic financial aspects of the project and hours/tasks per contract; escalates discrepancies.
• Reviews SOPs and Work Instructions; keeps training records updated and ensures timesheet compliance.
• Supports continuous improvement of SSU quality at the country level (submissions, essential document collection, communication to authorities).
• Prepare and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory submissions.
• Oversee site activation end to end process at country/site level.
• Supports country-level intelligence on start-up (SU) and clinical trial regulatory (CTR).
• Ensures local regulatory intelligence is maintained in the central repository.

Skills

Clinical Research Start-Up

Regulatory Affairs

Project Management

Cross-functional Collaboration

Excellent Communication

Job description

Syneos Health in Illinois seeks a Country Start-Up Specialist - Maintenance to manage country-level start-up tasks, regulatory submissions, and center activation for clinical trials. You will ensure SOP compliance, track timelines, and coordinate with EC/RA authorities while supporting continuous improvement of SSU processes.

Responsibilities include preparing local EC and RA submissions, maintaining TMF documents, and acting as a liaison between sites and line managers.