Role Overview
The Clinical Support Specialist (Site Contracts Dedicated) at Syneos Health operates within the Clinical Solutions function, providing operational, administrative, and coordination support across clinical trial activities. This role plays a critical part in ensuring smooth execution of site contract processes, documentation management, and project tracking while maintaining compliance with global clinical research standards. The position requires collaboration with cross-functional stakeholders and supports project timelines, risk mitigation, and audit readiness.
Core Responsibilities
Provide administrative and operational support across clinical functions, including coordination of project documentation and communications.
Manage shared mailboxes, organize project files, track action items, and ensure timely follow-up with stakeholders.
Maintain, update, and reconcile data within clinical tracking systems and project management tools.
Monitor timelines, milestones, and deliverables; identify delays, analyze root causes, and support development of contingency plans.
Technical & Operational Execution
Perform document management activities such as creation, compilation, formatting, version control, and quality control (QC).
Support translation of documents through approved vendors and systems.
Utilize AI-enabled tools, dashboards, and automated reporting systems to support operational decision-making and workflow optimization.
Assist in Trial Master File (TMF) management, ensuring proper filing and inspection-ready documentation.
Support audits and regulatory inspections by preparing and organizing required documentation.
Compliance & Quality Standards
Ensure adherence to Standard Operating Procedures (SOPs), Work Instructions (WIs), and country-specific regulatory requirements.
Maintain accurate records, including timesheets and compliance training documentation.
Deliver high-quality outputs aligned with project requirements and organizational standards.
Cross-Functional Collaboration
Work closely with clinical operations, project management, and contract teams to support project lifecycle activities.
Communicate effectively with stakeholders to resolve issues and ensure project alignment.
Support coordination across multiple projects and functions simultaneously.
Leadership & Mentorship
Provide training and mentorship to junior Clinical Operations Associates.
Support team development and knowledge sharing within the organization.
Organizational Impact
Ensures operational efficiency and timely execution of clinical trial activities.
Supports compliance and audit readiness, minimizing regulatory risks.
Contributes to successful clinical trial delivery by maintaining organized documentation and tracking systems.
Work Environment
Hybrid working model (office-based + remote flexibility) with shift timing from 2 PM to 11 PM.
Fast-paced, collaborative environment requiring multitasking and strong organizational skills.
Company Context
Syneos Health is a global life sciences services organization with extensive experience across drug development and commercialization.
The organization emphasizes innovation, collaboration, and career development, with exposure to global clinical trials and regulatory environments.