Description
Syneos Health is seeking a Country Start-up Specialist - Maintenance. As a key member of the Clinical Solutions team, you will be responsible for ensuring quality deliverables at the country level, following project requirements and applicable country rules. You will work closely with cross-functional teams to drive study start-up and maintenance activities.
Job Responsibilities
- Ensure quality deliverables at the country level, following project requirements and applicable country rules
- Monitor basic financial aspects of the project and escalate discrepancies in a timely fashion
- 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
Qualifications
- 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
- 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 participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time