Country Start-up Specialist – Maintenance

Syneos Health

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

Posted 10/7/2026full-timeRemote • Illinois • United StatesMid-LevelSenior💰 $56,400 - $95,900 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Clinical Research and Study Start-Up processes, ensuring compliance with ICH-GCP guidelines and local regulatory requirements. Proficient in managing regulatory submissions, stakeholder communication, and project management throughout the study lifecycle.

Highest-signal resume keywords

Clinical Research ExperienceRegulatory Affairs KnowledgeProject Management SkillsStakeholder EngagementICH-GCP Guidelines Understanding

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory SubmissionsStudy Activation ProcessesProtocol AmendmentsEssential Document CollectionQuality ControlSite SelectionBudget NegotiationSOP ComplianceTrial Master File ManagementData Protection Guidance

Soft Skills

Strong Communication SkillsInterpersonal SkillsOrganizational Skills

Tools & Technologies

SSU Tracking SystemTrial Master File

Industry Keywords

Clinical OperationsStudy Start-UpRegulatory ComplianceEthics Committee SubmissionsCountry Regulatory Intelligence

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 timelines and milestone progress in the SSU tracking system
Investigate delays, provide rationale, support contingency plans, and escalate issues
Monitor basic project financial aspects and contracted hours/tasks
Review and comply with SOPs and Work Instructions and maintain training records and timesheet compliance
Support quality improvement across country-level Site Start-Up components
Submit relevant documents to the Trial Master File
Prepare and submit Central EC, Local EC, RA, regulatory authority, and hospital approval applications
Prepare ongoing submissions, amendments, periodic notifications, safety notifications, and renewals
Liaise between investigational sites and functional leads and oversee end-to-end site activation
Maintain country regulatory intelligence and support data protection guidance
Provide input to local SOPs, Work Instructions, and internal training materials
Support EC or Competent Authority issue resolution
Support site selection and feasibility activities
Support country template contracts and budgets, negotiate site-specific contracts and budgets, perform quality control, arrange CTA execution, and archive documents
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
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 will also 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 participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
Flexible paid time off (PTO)
Sick time