Country Start-Up Specialist: Site Activation & Maintenance

Syneos Health, Inc.; Alton (IL); In loco; USD 56.000 - 96.000; Tempo pieno

Vantaggi offerti da questo lavoro

Company car

Health benefits

401k plan

Stock purchase plan

Bonus eligibility

Flexible PTO

Descrizione del lavoro

Syneos Health is seeking a Country Start-Up Specialist - Maintenance to manage country-level start-up activities, regulatory submissions, and site activation. You will ensure quality, timeliness, and regulatory compliance across studies, coordinating with multiple stakeholders and leading in-country maintenance efforts.

The role demands strong project management, expertise in ICH-GCP, and effective communication to support smooth trial initiation and ongoing regulatory compliance.

Competenze

• Experience in Clinical Research, Study Start-Up, Regulatory Affairs, Clinical Operations, or related functions.
• Experience managing country start-up activities, including regulatory and ethics committee submissions, essential document collection, and study activation.
• Experience supporting study maintenance activities, including amendments, continuing reviews, safety submissions, renewals, and ongoing regulatory compliance.
• Strong understanding of ICH-GCP guidelines and local regulatory requirements.
• Experience with multiple stakeholders (sponsors, CROs, investigator sites, regulatory authorities).
• Strong project management and organizational skills.
• Excellent written and verbal communication and interpersonal skills.
• Coordinate country start-up activities from study award through site activation.
• Prepare and submit regulatory and ethics committee packages for study initiation.
• Track country/site activation timelines and milestones per project plans.
• Manage ongoing study maintenance activities (amendments, renewals, annual reports, essential document updates).
• Support sites throughout the study lifecycle, ensuring regulatory compliance and operational readiness.

Mansioni

• Own quality deliverables at country level; follow project requirements and country rules; track milestones in SSU system.
• Monitor basic financials: hours/tasks per contract; escalate discrepancies as needed.
• Review and comply with SOPs/WIs; keep training records updated; ensure timesheet compliance.
• Support continuous improvement of SSU quality across submissions, essential documents, and regulatory communications.
• Ensure relevant documents are submitted to the TMF per SOP/Sponsor requirements.
• Serve as Local Submissions Specialist; follow country lead; may be PM/SAM contact; prepare/submit EC/RA applications and safety notifications.
• Liaise between investigational sites and functional leads; oversee end-to-end site activation at country/site level.
• Act as SME for in-country performance; maintain regulatory intelligence; support site ID/feasibility with study award through activation.

Descrizione del lavoro

Syneos Health is seeking a Country Start-Up Specialist - Maintenance to manage country-level start-up activities, regulatory submissions, and site activation. You will ensure quality, timeliness, and regulatory compliance across studies, coordinating with multiple stakeholders and leading in-country maintenance efforts.

The role demands strong project management, expertise in ICH-GCP, and effective communication to support smooth trial initiation and ongoing regulatory compliance.