Job Responsibilities

Job 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 trials submissions. Accountable to functional leads for project level deliverables, and to line manager for performance across projects.

Core Responsibilities

- 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

Additional responsibilities

- 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; escalate 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.

- 1 to 2 years of clinical operations experience

- Provide operational and administrative support to CRAs and Country Regulatory Specialists within the site activation and regulatory submissions functions.

- Must have experience with Local Packages (Ethics Committee) submissions.

- Site/Study startup experience (part of operations). Good understanding in clinical research, drug discovery, clinical trials (setup, maintenance, closeout).

- Must have good communication (Verbal & Written)

- 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 energetic 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 rapidly changing environment and learn/perform new functions.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Clinical Support Specialist II (Hyderabad)
🏢 Syneos Health
📍 Hyderabad