Country Start-Up Specialist

Syneos Health

. Responsible for quality deliverables at the country level and compliance with project requirements and applicable country rules .

Posted 11/5/2026full-timeRemote • Illinois • United StatesMid-LevelSenior💰 $56,400 - $95,900 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Research and Study Start-Up processes, including regulatory submissions and compliance with ICH-GCP guidelines. Proven ability to manage country-level start-up activities and liaise effectively with multiple stakeholders throughout the study lifecycle.

Highest-signal resume keywords

Clinical Research ExperienceRegulatory Affairs KnowledgeProject Management SkillsStrong Communication SkillsStakeholder Engagement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsStudy Activation ProcessesProtocol AmendmentsSafety SubmissionsEssential Document CollectionQuality ControlContract NegotiationBudget ManagementSOP ComplianceData Protection Guidance

Soft Skills

Organizational SkillsInterpersonal SkillsWritten CommunicationVerbal CommunicationProblem-Solving

Tools & Technologies

SSU Tracking SystemTrial Master File

Industry Keywords

ICH-GCP GuidelinesClinical OperationsStudy Start-UpEthics Committee ApplicationsRegulatory Authority ApplicationsSite ActivationCountry-Level ComplianceStakeholder ManagementStudy Maintenance ActivitiesLocal Regulatory Requirements

About the role

Key responsibilities & impact

Responsible for quality deliverables at the country level and compliance with project requirements and applicable country rules
Track submission and approval milestones in the agreed SSU tracking system and investigate or escalate timeline delays
Monitor basic project financial aspects and contracted hours/tasks
Review and comply with SOPs and Work Instructions, maintain training records, and ensure timesheet compliance
Support quality improvement across country-level Site Start-Up components
Submit relevant documents to the Trial Master File
Prepare and submit central and local ethics committee applications, regulatory authority applications, and other local approval submissions
Prepare ongoing submissions, amendments, periodic notifications, safety notifications, renewals, and other regulatory maintenance activities
Liaise between investigational sites and functional leads and oversee site activation end to end
Act as a country-level Site Start-Up subject matter advisor and maintain regulatory intelligence
Support data protection guidance, local SOPs, work instructions, and internal training materials
Assist with ethics committee or competent authority issue resolution
Support site selection and feasibility activities
Support investigator contract and budget negotiation, contract execution, quality control, archival, and metadata capture
Coordinate country start-up activities from study award through site activation
Support sites throughout the study lifecycle to ensure regulatory compliance and operational readiness

Requirements

What you’ll need

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
Experience supporting study maintenance activities, including protocol amendments, continuing reviews, safety submissions, renewals, and ongoing regulatory compliance
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
Equivalent experience, skills, and/or education may be considered

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition and total rewards program
Company car or car allowance
Medical, dental, and vision health benefits
Company match 401k
Eligibility to earn commissions/bonus based on company and individual performance
Flexible paid time off (PTO)
Sick time