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Clinical Support Specialist – Regulatory, Study Start-Up, Site Activation
Syneos Health. Provide operational and administrative support to one or more clinical functions .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates proficiency in clinical operations and project management, with strong skills in documentation, communication, and the use of AI-enabled tools for organizational support. Capable of maintaining quality outputs while adhering to project requirements and compliance standards.
Highest-signal resume keywords
Clinical Operations ExperienceMicrosoft Office Suite ProficiencyDocument Management SkillsProblem-Solving TechniquesAttention to Detail
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical OperationsDocument ManagementProject TrackingQuality ControlVersion ControlTimeline TrackingSOP ComplianceTraining CompletionAction Item TrackingDocument Creation
Soft Skills
Effective CommunicationTeam-Oriented ApproachOrganizational SkillsFlexibilityIndependence
Tools & Technologies
AI-Enabled ToolsDashboardsClinical Tracking SystemsMicrosoft OutlookMicrosoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Publisher
Certifications & Qualifications
Associate's Degree
Industry Keywords
Clinical ResearchTrial Master FileInspection-Ready DocumentationSOPsWork Instructions
About the role
Key responsibilities & impact- Provide operational and administrative support to one or more clinical functions
- Coordinate documentation and communications, including managing shared mailboxes, organizing project files, tracking action items, and following up with cross-functional stakeholders
- Enter, maintain, and reconcile information in project and clinical tracking systems
- Track timelines and milestones
- Perform document management, including document creation, compilation, formatting, version control, and quality control
- Translate documents using approved vendors or systems
- Use AI-enabled tools, dashboards, and automated reports for logistical, organizational, and analytical support
- Support Trial Master File filing and related document processes, ensuring inspection-ready documentation
- Deliver quality outputs while following project requirements and applicable country rules
- Review and comply with SOPs and Work Instructions, complete required training, and maintain accurate timesheet reporting
- Monitor workload, scope, budgeted effort, and project hours; escalate discrepancies promptly
- Maintain awareness of clinical research through assigned training
Requirements
What you’ll need- Associate’s degree or equivalent combination of education, training and experience
- Minimum 1 year clinical operations experience
- Demonstrated understanding of clinical operations
- Effective problem-solving techniques
- Strong documentation and communication skills in written and spoken English
- Team-oriented approach
- Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Publisher)
- Ability to learn and adopt new technologies and tasks, including AI-enabled tools and dashboards where approved/available
- Ability to manage competing priorities in a dynamic, fast-paced environment
- Ability to work independently and as part of a team
- Good organizational skills and attention to detail
- Ability to take direction from multiple individuals and set priorities accordingly
- Quality-driven approach
- Flexibility and willingness to adapt to a rapidly changing environment and learn/perform new functions
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations when appropriate