Country Start-Up Specialist: Regulatory & Site Activation

Syneos Health/ inVentiv Health Commercial LLC; Chicago (IL); On-site; USD 56,000 - 96,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits

401k match

Employee Stock Purchase Plan

Bonus eligibility

Flexible PTO

Job summary

Syneos Health is seeking a Country Start-Up Specialist - Maintenance to lead country level quality, submissions, and site activation activities. You will work under the SSU structure, coordinating with country managers, regulators, and sites to ensure timely, compliant start-up and ongoing maintenance across trials.

The role requires strong ICH-GCP knowledge, stakeholder management, and project management, with demonstrated experience in regulatory affairs and study start-up.

Qualifications

• Experience in Clinical Research, Study Start-Up, Regulatory Affairs, or related functions.
• Experience managing country start-up activities, including regulatory submissions and site activation.
• Experience with protocol amendments, continuing reviews, and safety submissions.
• Strong knowledge of ICH-GCP guidelines and local regulatory requirements.
• Ability to coordinate with sponsors, CROs, investigators, and authorities.
• Excellent project management and communication skills.

Responsibilities

• Ensure quality deliverables at country level and meet submission timelines.
• Monitor financial aspects and hours per contract; escalate discrepancies.
• Follow SOPs and WI; keep training records and timesheet compliance.
• Support continuous quality improvement of SSU components.
• Submit regulatory and ethics filings (EC/RA) as required.
• Act as liaison among sites and leads; oversee site activation end-to-end.
• Provide input to local regulatory documents and SOPs.

Skills

Clinical Research

Country Start-Up

Study Maintenance

ICH-GCP

Stakeholder Management

Project Management

Communication

Country Start-Up Coordination

Regulatory Submissions

Timeline Tracking

Ongoing Maintenance

Site Support

Job description

Syneos Health is seeking a Country Start-Up Specialist - Maintenance to lead country level quality, submissions, and site activation activities. You will work under the SSU structure, coordinating with country managers, regulators, and sites to ensure timely, compliant start-up and ongoing maintenance across trials.

The role requires strong ICH-GCP knowledge, stakeholder management, and project management, with demonstrated experience in regulatory affairs and study start-up.