Clinical Support Specialist – Regulatory, Study Start-Up, Site Activation (Buenos Aires)

Clinical Support Specialist – Regulatory, Study Start-Up, Site Activation (Buenos Aires)

07 sep
|
Jobtailor
|
Buenos Aires

07 sep

Jobtailor

Buenos Aires

- Provide operational and administrative support to one or more clinical functions
- Coordinate documentation and communications, including maintaining and managing shared mailboxes, organizing project files, tracking action items, and ensuring timely follow-up with cross-functional stakeholders
- Enter, maintain, and reconcile information in agreed 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/systems
- Use AI-enabled tools, dashboards, and automated reports to provide logistical, organizational, and analytical support
- Support Trial Master File (TMF) filing and related document process activities within scope, ensuring inspection-ready documentation
- Provide quality deliverables and follow project requirements and applicable country rules
- Review and comply with applicable SOPs and Work Instructions, ensure training compliance, and maintain accurate timesheet reporting




- Monitor workload/scope, budgeted effort, and project hours; escalated discrepancies in a timely manner
- Maintain awareness of clinical research by completing necessary and assigned training

Requirements
- Associate’s degree or equivalent combination of education, training and experience.
- Minimum 1 year clinical operations experience
- Demonstrated understanding of clinical operations
- Utilize problem-solving techniques effectively
- Strong documentation and communication skills (written and spoken English)
- Team-oriented approach
- Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Publisher)
- Ability to embrace new technologies and 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
- Demonstrated ability to work independently as well as part

📌 Clinical Support Specialist – Regulatory, Study Start-Up, Site Activation (Buenos Aires)
🏢 Jobtailor
📍 Buenos Aires

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