Country Start-up Specialist – Maintenance

🔥 0 minutes ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $56.4k - $95.9k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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

• 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

• 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