Country Start-Up Specialist -US

Syneos Health is seeking a Country Start-Up Specialist -US. As a Country Start-Up Specialist, you will be responsible for the quality deliverables at the country level, following project requirements and applicable country rules with moderate oversight from the SSU Country Manager.

Responsibilities:

• Monitor and ensure compliance with forecasted submission/approval timelines and track milestone progress in real-time
• Investigate and provide clear rationale for delays, provide support on contingency plans, and escalate issues as needed
• Review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner
• Support continuous improvement of quality in all Site Start-Up (SSU) components at the country level
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements
• Act as a point of contact for the PM/SAM (or designee) during start-up on allocated projects
• Prepare and submit regulatory and ethics committee packages to support study initiation
• Track country and site activation timelines, ensuring milestones are achieved according to project plans
• Manage ongoing study maintenance activities, including amendments, renewals, annual reports, and essential document updates

Requirements:

• Experience in Clinical Research, Study Start-Up, Regulatory Affairs, Clinical Operations, or related functions
• Bachelor's degree required
• Demonstrated experience managing country start-up activities, including regulatory and ethics committee submissions, essential document collection, and study activation processes
• Strong understanding of ICH-GCP guidelines and local regulatory requirements
• Experience working with multiple stakeholders, including sponsors, CROs, investigator sites, and regulatory authorities
• Strong project management and organizational skills
• Strong written and verbal communication and interpersonal skills

Benefits:

• Company car or car allowance
• Health benefits, including Medical, Dental, and Vision
• Company match 401k
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO) and sick time