Postúlate en Kit Empleo: kitempleo.com.ar/empleo/om8rl

Clinical Support Specialist II or Senior (adecuado opportunity for CTAs or SAS with regulatory experience - Argentina Hybrid)

Description

Clinical Support Specialist II or Senior (ideal opportunity for CTAs or SAS with regulatory experience - Argentina Hybrid). Syneos Health® is a leading fully‑integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Job Responsibilities

- Responsible for providing operational and administrative support to one or more clinical functions.
- Responsibilities may include but are not limited to:
- Provide administrative support by coordinating 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.
- Timeline and milestone tracking.
- Perform document management activities including document creation, compilation, formatting, version control, and quality control (QC).
- Translation of 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.
- Responsible for providing quality deliverables. Follow project requirements and applicable country rules, with oversight at the project level from functional leads.




- Review and comply with applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs), ensure training compliance, and maintain accurate timesheet reporting.
- Monitor workload/scope, budgeted effort, and project hours; elevate discrepancies in a timely manner.
- Maintains overall awareness in the field of clinical research by completing all necessary and assigned training.

Qualifications

- 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) as well as a team‑oriented approach.
- Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Publisher) and ability to embrace new technologies and demonstrate ability to learn and adopt new technologies and tasks (including AI‑enabled tools and dashboards where approved/available).
- Ability to manage competing priorities and work in a dynamic fast‑paced environment.
- Demonstrated ability to work independently as well as part of a team.
- Good organizational skills and attention to detail, proven ability to take direction from multiple individuals and set priorities accordingly.
- Quality‑driven in all assigned activities.




- Flexibility and willingness to adapt to a rapidly changing environment and learn/perform new functions.

Summary

The position is responsible for providing operational and administrative support, with limited supervision, to one or more clinical functions, including but not limited to Project Management, Site Management, Data Management, Biostatistics, Medical Writing, Site Selection, Site Activation, Site Contracting and regulatory clinical trial submissions. Accountable to functional leads for project‑level deliverables, and to line manager for performance across projects.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties and job responsibilities. Equivalent experience, skills, or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.

Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

#J-18808-Ljbffr

Postúlate en Kit Empleo: kitempleo.com.ar/empleo/om8rl

📌 Clinical Support Specialist II or Senior (ideal opportunity for CTAs or SAS with regulatory exp[...] (Buenos Aires)
🏢 Syneos Health
📍 Buenos Aires