Clinical Support Specialist – Regulatory & Site Activation (Hybrid)

About the role

Join Syneos Health’s Clinical Solutions team as a Clinical Support Specialist, providing operational and administrative support for regulatory, study start‑up and site activation activities in a hybrid work setting.

Key responsibilities

• Coordinate documentation and communications, manage shared mailboxes, organize project files and track action items with cross‑functional stakeholders.
• Enter, maintain and reconcile data in project and clinical tracking systems, monitor timelines and milestones.
• Perform document management tasks including creation, formatting, version control, quality control and translation using approved vendors.
• Support Trial Master File (TMF) filing and ensure inspection‑ready documentation.
• Utilize AI‑enabled tools, dashboards and automated reports to provide logistical and analytical support.
• Monitor workload, budgeted effort and project hours, escalating discrepancies as needed.

Required profile

• Associate’s degree or equivalent experience.
• Minimum 1 year of clinical operations experience with a solid understanding of clinical processes.
• Strong documentation and communication skills in written and spoken English.
• Ability to manage competing priorities in a fast‑paced environment and work both independently and as part of a team.

Required skills

• Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Publisher).
• Experience with AI‑enabled tools and dashboards where approved/available.
• Document management and version control capabilities.