# Country Start-Up Specialist -US

**Company**: Syneos Health
**Location**: Remote, IL
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Salary**: $56,400.00 - $95,900.00
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/USA-IL-Remote/Country-Start-Up-Specialist--US_25114190?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_59a58045-83b

## Description

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

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## Skills

### Required
- Clinical Research
- Study Start-Up
- Regulatory Affairs
- Clinical Operations
- ICH-GCP guidelines
- Project Management

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/USA-IL-Remote/Country-Start-Up-Specialist--US_25114190?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)